FDA Compliance Career Careers in the United States

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Director Of Regulatory Compliance - GMP

Summary: Reporting to the Vice-President of Quality Assurance & Regulatory Affairs, the Director of Regulatory Compliance will assist in establishing the vision, strategy, management, visibility, and evolution of regulatory compliance for the Cardiac Sc...

Quality Assurance Compliance Manager

PROMOTECH's promise has been to meet the growing needs of pharmaceutical, healthcare, biotech and communication organizations for over 14 years. We offer four exceptional resources: Telemarketing/Teledetailing Direct Mail Fulfillment/Warehousing Dat...

Regulatory Affairs Specialist

Role: Regulatory Affairs Specialist Location: Cleveland, OH Job Type: Full Time Description: Candidate Responsibilities: Responsible for key program/project deliverables by developing Quality and Regulatory project plans. Participates in pr...

5/2 STILL OPEN: Quality Assurance Engineer

This is a great opportunity to work for a pharmaceutical company in Delaware. I am looking for a Quality Engineer to ensure compliance with FDA and other regulatory requirements, and to handle FDA compliance on product complaints. Will assure that all pro...

PLASTICS ENGINEER - MEDICAL DEVICE MANUFACTURING

Our client is a manufacturer of plastic products for the medical industry. Continued growth has created an urgent need for a highly skilled Plastics Engineer to lead key projects in improving plastic molding and assembly processes. If you are a Plastic...

Sr. Quality System Specialist - FDA/Regulatory

Healing the healthcare system starts with you. It starts with the chain of events you initiate when you work with McKesson Provider Technologies - a chain that extends across the country and results in millions of people getting more from their healthcare...

Manager - FDA Software Quality - V&V

Responsibilities: A San Diego company is currently looking for a Software Quality Manager. The right person would provide guidance and leadership to the product development team in the planning and execution of the development of new products.Kforce (...

Director of Donor Services

Organization Blood Bank of Delmarva (BBD) is a non-profit community service organization that provides blood and blood products to 16 hospitals on the Delmarva Peninsula. Blood Bank of Delmarva's mission is to serve our community by meeting the needs of...

Vice President, Regulatory Affairs & Quality Assurance

The VP, Regulatory Affairs and Quality Assurance is responsible for the development, implementation and surveillance of CardioNet product Quality Systems in accordance with FDA QSR, ISO13485, and other applicable regulations; responsible for management of...

Director, Regulatory Compliance

Director, Regulatory Compliance Summary: Reporting to the Vice-President of Quality Assurance & Regulatory Affairs, the Director of Regulatory Compliance will assist in establishing the vision, strategy, management, visibility, and evolution of r...

Plant Manager - Healthcare

Join LifeGas, a leading gas therapy and respiratory solutions provider across the care continuum. We provide high quality medical gases and gas-enabled medical solutions and utilize these solutions to assist our clients in their management of various medi...

Sr. Director, Regulatory Compliance

Overview: Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play...

Regulatory Affairs

We have multiple positions at various levels in the Chicagoland area requiring food & beverge regulatory experience. In all cases, they are the point person for all internal and externally requested regulatory information within the organization. All reg...

Sr. Quality Engineer

Sr. Process Quality Engineer A local Medical Device company is looking to add an Engineering to it's Quality Team. This is a great opportunity to get in the door with a large, stable and global company. They are looking for an Engineer with a solid...

Clinical Pharmacist

Direct Hire Opportunity: Clinical Pharmacist : Will be in charge of the pharmacy operations and staff. Including IP, GCPs, SOPs, and FDA guidelines and all applicable rules and regulations. MUST HAVE the following: Pharmacy Degree Valid cu...

Sr Compliance Engineer

Looking for a SR Compliance Engineer for revision of Risk Management documentation for existing products to be in compliance with internal procedures and external standards requirements. This position is needed to bring BDC in compliance with the Globa...

REGULATORY AND COMPLIANCE MANAGER

Our client of 7 years, is a Pharmaceutical Company recognized globally for their unparalleled development and manufacturing services for the world?s leading pharmaceutical, biotechnology, and healthcare companies. With four cGMP facilities and over...

Sr. Complaints Analyst and MDR Coordinator

Company Description Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurger...

Quality Systems and Compliance Specialist

Are you an enthusiastic individual who thrives in a fast-paced work environment? Then this may be the perfect fit for you! Sterilmed , a member of Johnson & Johnson's Family of Companies, is recruiting for a full-time Quality Systems and Compl...

Chemistry Lab Supervisor

Chemistry Supervisor Food Safety Net Services is a leading analytical food-testing laboratory with multiple U.S. locations. Our corporate office is in San Antonio Texas. We are seeking a proven Chemistry Supervisor with the drive, energy and technical...

Associate Director, Clinical Compliance

Job Description: Reporting to the Sr. Director Clinical Compliance and Process Improvement, this position will provide guidance and leadership in the investigation, correction and prevention of potential GCP Compliance issues at investigator sites, CRO...

Sanitation Supervisor

Sanitation Supervisor Position Purpose: Ensures complete sanitation processes are maintained to company standards and in compliance to all related regulatory agencies in order to meet manufacturing goals. Develops and maintains Sanitation Standard...

Manager Quality Engineering and Compliance ? UT

Position Title: Manager Quality Engineering and Compliance ? UT #1493 Relocation: Yes Location: Salt Lake City, UT Bottom line, the qualified candidate must have: 1. Bachelor's Degree. 2. Quality Engineering experience in Industrial Chemical Manu...

Medical Records Coordinator

The candidate will have experience in the following: -Responsible for accurately triaging and prioritizing all medical record follow up to cases in U.S. litigation per FDA regulatory guidelines and our SOPs -Prioritization and extraction of all incomi...

Clinical Quality Manager GCP

Clinical Quality Manager GCP Our client is an industry leader in occulat therapy. They are in a very exciting, growth phase and are currently seeking the talents of a Clinical Quality professional to help lead them into the next phase of product. Please...

Compliance Specialist

Zep Inc. (NYSE: ZEP) is a leading provider of specialty chemical products to a wide variety of industrial, institutional, and retail customers. Zep Inc. has a solid presence throughout America and in the international marketplace, reaching into every majo...

Sr. Process Engineer

Our Client - a growing consumer goods company with worldwide sales of $3B+ and 6K+ people needs a Senior Process Engineer at their location in Indiana . Excellent Salary + bonus + full relocation Job Posting # 1347 Job Title : Sr. Process Engi...

Quality Systems Manager

Standard Homeopathic Company a well established pharmaceutical manufacturing company has exciting opportunities for a Quality Systems Manager. Our company is over 100 years old and robustly growing. The Quality Systems Manager is responsible for the...

Quality & Regulatory Manager

Connecting patients to the right care starts with you. It starts with the chain of events you initiate when you work with RelayHealth, (A McKesson company) - a chain that extends across the country and results in millions of people getting more from their...

Regulatory / Compliance Manager

Regulatory / Compliance Manager We have an excellent opportunity available for a Regulatory / Compliance Manager to work in Rochester NY. Job Responsibilities: - Manage the Regulatory Affairs function - Ensure compliance with Domestic an...

Director of Quality Assurance and Regulatory Affairs

Main Objective: Manages the daily operations of the Quality Assurance and Regulatory Affairs department and assures regulatory submission compliance for California Operations. Maintains understanding and compliance requirements of regulatory affairs aff...

Food Scientist #5291

Company Well established, growing food manufacturer with 50 year history Leading manufacturer of nationally recognized retail, club, and foodservice branded products Benefits and Features Medical, dental, and vision insurance Employer p...

Senior Quality Engineer (Medical Device)

Are looking for an exciting opportunity with one of the nation's fastest growing organizations? If so, than this is the opportunity for you!! Our client has multiple full time opportunities that are all located in central Pennsylvania. Only apply if re...

Airline/Ramp Safety Supervisor

LSG Sky Chefs is the world?s largest provider of in-flight services. These include airline catering, in-flight equipment and logistics, as well as the management of onboard service and in-flight retail. The group is also the industry leading expert in man...

Manager, Regulatory Affairs and Quality Assurance

Airway Management, Inc. (AMI) is committed to offering products that improve the health and quality of life for people who suffer from sleep-disordered breathing. Our goal is to support the laboratory technician and practitioner with high quality, minimal...

Quality Packaging Supervisor

QA Supervisor, Packaging Function: Provide supervisory direction in the execution of regulatory and quality assurance plans designed to meet government approval for new/existing products. Act as a liaison support for all activities related to...

Nutritional Development Specialist

Nutritional Development Specialist Nutritional Development Specialist Info - Our client located in Providence, RI is a diversified food processor in high quality food products such as soups, salads, and dips. SCOPE OF POSITION: The posit...

Regulatory Affairs Manager

Who We Are BSN medical is a global medical device company - and one of the world?s leading suppliers in the product segments of casting, bandaging, wound care and compression stockings. Several of our well-known brands ? Leukoplast®, Leukomed® G...

Manufacturing Engineer

TearScience is dedicated to delivering relief for sufferers by identifying and treating the primary cause of Dry Eye, lipid deficient or evaporative dry eye. Backed by funding from top tier medical device venture funds, TearScience® is uniquely positioned...

Sr. Quality Manager

Sr. Quality Manager Industry leading pharmaceutical company seeks a Sr. Quality Manager to drive all operations compliance programs at the company's manufacturing site in suburban St. Louis, MO. The Sr. Quality Manager will have direct supervision as...

Quality Assurance Director

Hamilton Company is a global enterprise with manufacturing facilities in Reno, Nevada and Bonaduz, Switzerland. Branch sales offices are located in France, Germany, and the United Kingdom. We are the worldwide leader in the design and manufacture of manua...

VP - Director of Quality & Regulatory

VP or Director of Quality Control (CAPA) & FDA Regulatory Compliance Opportunity This is a unique opportunity for a Quality Control Management Professional to join a rapidly expanding, yet proven and stable organization. This company is an establi...

Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs Job Duties Include Report to the Director/Sr. Director Regulatory Affairs. Interact with key company personnel both within and outside of the US as related to assigned projects. Develop and mainta...

Product Steward

Styrolution America, LLC, was founded on October 1, 2011, as a joint venture between BASF and INEOS. Working at Styrolution is more than just doing a job, it?s a passion. Everything we do and every choice we make is guided by our company values. It tak...

Director, Quality Assurance

The Director of Quality Assurance will direct and manage all day-to-day activities of the company's quality management program to ensure compliance with all federal and international regulations. This individual will provide strategic direction, oversight...

Lead Regulatory Affairs Specialist

Join STERIS in its vision to see the world free from Infection and Contamination as a Lead Regulatory Specialist Summary The mission of the Regulatory Affairs Submissions and Registrations function is to implement efficient and effect...

Quality Manager

Hospital Specialty Company in Nicholasville, KY is seeking a Quality Manager. Hospital Specialty Company manufactures and distributes adult incontinence and feminine hygiene products. The plant has been in the Nicholasville, KY area since 1979. Hospital S...

Quality (QA/QC) and R&D Pharmaceutical Careers Nationwide

ONLY APPLY IF YOU HAVE 3+ YEARS OF QA OR QC PHARMACEUTICAL OR BIOTECH EXPERIENCE. ASSOCIATE DIRECTOR, QUALITY ASSURANCE, RHODE ISLAND Responsible for all daily quality assurance and GMP compliance to ensure compliance with all requirements related t...

QA Advisor / Quality Manager

Provides interpretation of ICH 2001 Q7 / Good Manufacturing Practice (GMP) Guidance and other regulatory documents such that critical actions relating to active pharmaceutical ingredient (API) and cGMP production will be judged as reasoned, defendable, an...

AVP-Regulatory CMC

Job Description: The Associate VP is responsible for driving global Regulatory CMC strategy development; and for development and execution of Regulatory plans (filing strategies, preparation, submission and approval) for assigned biologic development...

DIRECTOR OF RA / QA

IMDS , an industry leader in the design and manufacture of orthopedic medical devices, is seeking qualified DIRECTOR OF RA / QA candidates to support the Logan, UT Product Sourcing facility. This position reports to the General Manager and serves as a...

Vice President of Regulatory Affairs and Quality Assurance

PURPOSE OF POSITION: The Vice President of Regulatory Affairs and Quality Assurance will provide leadership for the development, implementation, communication and maintenance of quality systems policies and procedures for the company as well as provide...

Quality Engineer

Job Classification: Direct Hire We are seeking a Quality Engineer to join our team!! In this position you will provide leadership, direction and have hands on involvement to ensure manufacturing processes conform to GMP, FDA and ISO standards. This...

Production Manager - mills, lathes, edm, swiss, medical

Production Manager ? cnc milling, lathes, edm, swiss lathes, medical A international corporation producing spinal implants and surgical instruments is searching for a leader of their state of the art spinal implant machining cells. We are searching...

Senior Research Associate, Outcomes Research

Relocation Approved: Yes Education Required: Masters Function: Research & Scientific Senior Research Associate Provides scientific leadership within project teams either independently and/or collaboratively with research scientists, i...

Product Integrity Specialist

Summary - The Product Integrity Specialist is responsible for execution, implementation and continual improvement of established quality management policies and procedures. The Product Integrity Specialist will take direction on quality matters from subj...

Quality Compliance Auditor

The mission of Altria Group, Inc. is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products. Altria Group is the parent company of Philip Morris USA,...

ASSOCIATE DIRECTOR OF MANUFACTURING - Pharmaceuticals

ASSOCIATE DIRECTOR OF MANUFACTURING ? Pharmaceuticals The Associate Director of Manufacturing will have experience in pharmaceutical production, and knowledge of FDA and GMP regulations as they apply to the manufacture of drugs and related product...

Quality Assurance / Food Safety Manager

SUMMARY: Responsible for the overall design, implementation and management of the product quality and food safety programs for a fresh-food manufacturing organization. Monitors compliance with USDA, FDA and other regulatory as well as with customer, cor...

Quality Compliance Specialist

Quality Compliance Specialist Duties: Perform Regulatory Compliance Audits as needed Self Inspections, Supplier, and Third Party Audits Manage audit lifecycle (audit report, CAPA follow up) using Sentry Trackwise database. Follow up on CAPA actio...

Quality Assurance and Regulatory Affairs Leader

The Area ? Quality Assurance and Regulatory Affairs Dedication, precision and the ongoing pursuit of excellence define our commitment to quality. We require vision and expertise to support our staff with the resources required to become true masters of...

Senior Regulatory Affairs Specialist -Devices

PURPOSE AND SCOPE: Supports FMCNA?s mission, vision, core values, and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Under general supervision is respons...

SENIOR MANUFACTURING QUALITY ENGINEER

The Senior Manufacturing Quality Engineer provides Manufacturing systems expertise, knowledge, and leadership in support of an instrument or product line. The incumbent defines and maintains the necessary processes and procedures that ensure that statisti...

Unix Storage Administrator - II (Infrastructure Projects)

We are seeking a candidate that is able to be Responsible for participating in storage management projects such as Release Management , product upgrades, compatibility, and dependencies, as well as remote site replication, GxP/FDA documentation, lab testi...

QA Manager

Our major biotech client is looking for Quality Assurance (QA) Manager III for a 4 month contract position (W2) located in Woburn, MA . Summary: Responsible for the development, implementation and maintenance of Quality Assurance systems and a...

Data Reviewer

JOB SUMMARY: Under the direction of a laboratory Management, this individual: - Performs critical in-depth reviews of scientific data for all documents (including, but not limited to, laboratory notebooks, reports, and materials for ANDA submissio...

Quality Compliance (QA) Specialist

Our client is is offering an opportunity to join a world class company known for its excellence in R&D. Consider the possibility. Summary: Our client is currently seeking a talented and motivated Quality Compliance Specialist to join its QA departme...

Sr. Clinical Research Associate

ARE YOU COVIDIEN? As a global, $11+ billion healthcare products leader, we deliver outstanding results and innovative solutions for challenging problems. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the...

Mid-to Senior-Level Associate

DC office seeks a mid-to senior-level associate with 5+ years of experience representing life sciences companies in the pharmaceutical, medical device, biologics, cosmetics and/or food industries on a variety of regulatory issues. Candidates should have e...

Vice President, Quality and Regulatory Affairs

Responsible for the management of all of the quality systems, which includes maintenance and improvement of existing systems as well as identifying and implementing new quality systems within the company?s manufacturing and quality functions Responsible...

Quality Assurance Manager-Food Production

Industry leading global company is seeking a Quality Manager in Boston, MA. Role Purpose Statement: The job incumbent is responsible for the implementation, auditing, assessing and training of quality systems at the Operations facility. Duties...

Drug Safety Associate III

Duration: 6+ months contracting Description: Responsible for participating in the collection, safety review, processing and reporting of adverse events data in compliance with applicable FDA and global regulations and Janssen AI Standard Operating Pro...

Product Safety Manager

Manage compliance department staff and projects. Manage document data base for test reports and submission of GCC requirements. Ensure all testing submissions are in compliance with required guidelines. Review proposed product artwork for accuracy...

Associate Manager, International Trade Compliance

For more than 110 years, The J.M. Smucker Company has been committed to offering consumers quality products that bring families together to share memorable meals and moments. Today, Smucker is a leading marketer and manufacturer of fruit spreads, retail...

Director Regulatory Affairs & Regulatory Compliance

We currently have an excellent opportunity for a Director, Regulatory Affairs & Regulatory Compliance located at our Princeton NJ headquarters.The Director, Regulatory Affairs & Regulatory Compliance serves as the primary corporate contact with all Lo...

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