The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by ...
The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by ...
Job Purpose and Impact The Food Safety Quality and Regulatory Associate, will ensure internal collaboration and connectivity for all policies, standards and trainings. In this role, you will partner ...
New
Job Purpose and Impact The Food Safety Quality and Regulatory Associate, will ensure internal collaboration and connectivity for all policies, standards and trainings. In this role, you will partner ...
New
The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by ...
Quick apply
The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$240 - $280/hr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$240 - $280/hr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Job Purpose and Impact The Food Safety Quality Regulatory Coordinator will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Coordinator will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Coordinator will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Coordinator will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$159K - $210K/yr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$159K - $210K/yr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$159K - $210K/yr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Head of Quality & Regulatory Affairs - Autoimmunity
San Diego, CA ยท On-site
$159K - $210K/yr
Overview Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the ...
Head of Quality & Regulatory Affairs (Richmond)
Richmond, VA ยท On-site
$148K - $196K/yr
The Head of Quality & Regulatory Affairs is responsible for the development and administration of M4ALL's inaugural Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs functions, in ...
Head of Quality & Regulatory Affairs (Richmond)
Richmond, VA ยท On-site
$148K - $196K/yr
The Head of Quality & Regulatory Affairs is responsible for the development and administration of M4ALL's inaugural Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs functions, in ...
Head of Regions Quality Management and Regulatory Affairs
$153K - $202K/yr
Lead the Regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, driving a harmonized, standardized, and high-performing operating model that ensures ...
Head of Regions Quality Management and Regulatory Affairs
$153K - $202K/yr
Lead the Regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, driving a harmonized, standardized, and high-performing operating model that ensures ...
Head of Quality Regulatory will provide uncompromising attention to detail, solving and managing quality issues for packaging and beauty lab production orders. Quality issues are problems attributed ...
Head of Quality Regulatory will provide uncompromising attention to detail, solving and managing quality issues for packaging and beauty lab production orders. Quality issues are problems attributed ...
POSITION OBJECTIVE The Specialist, Air Quality Regulatory Compliance is responsible for supporting the Manager, Air Quality Regulatory Compliance and other staff with corresponding programs. This ...
POSITION OBJECTIVE The Specialist, Air Quality Regulatory Compliance is responsible for supporting the Manager, Air Quality Regulatory Compliance and other staff with corresponding programs. This ...
Senior Product Quality & Regulatory Analyst
Santa Clarita, CA ยท On-site
$75.10 - $142.60/hr
... quality in the medical device industry. The role involves collaborating with cross-functional partners to ensure compliance with regulations and improve processes using data-driven insights. This ...
New
Senior Product Quality & Regulatory Analyst
Santa Clarita, CA ยท On-site
$75.10 - $142.60/hr
... quality in the medical device industry. The role involves collaborating with cross-functional partners to ensure compliance with regulations and improve processes using data-driven insights. This ...
New
Vice President, Food Safety, Quality & Regulatory Affairs Location: JFK Flight Kitchen - Queens, NY DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to ...
Vice President, Food Safety, Quality & Regulatory Affairs Location: JFK Flight Kitchen - Queens, NY DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to ...
Job Purpose and Impact The Food Safety Quality Regulatory Location Lead will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Location Lead will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Location Lead will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Job Purpose and Impact The Food Safety Quality Regulatory Location Lead will provide specialized knowledge of specific segments of quality systems or plant processes such as food safety and quality ...
Associate Director, R&D Quality & Regulatory Intelligence
Boston, MA ยท On-site
$160.60 - $240.80/hr
Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for establishing and enhancing the R&D Quality Regulatory ...
New
Associate Director, R&D Quality & Regulatory Intelligence
Boston, MA ยท On-site
$160.60 - $240.80/hr
Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for establishing and enhancing the R&D Quality Regulatory ...
New
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Chromalloy is seeking a Regulatory Compliance Leader to provide enterprise-wide leadership for aviation regulatory compliance and quality systems across our aerospace manufacturing, repair, and PMA ...
Quality And Regulatory information
See salary details
$12.26 - $14.07
4% of jobs
$14.07 - $15.89
19% of jobs
$16.06 is the 25th percentile. Wages below this are outliers.
$15.89 - $17.70
17% of jobs
The median wage is $18.72 / hr.
$17.70 - $19.51
17% of jobs
$19.51 - $21.33
12% of jobs
$22.33 is the 75th percentile. Wages above this are outliers.
$21.33 - $23.14
11% of jobs
$23.14 - $24.96
7% of jobs
$24.96 - $26.77
5% of jobs
$26.77 - $28.58
3% of jobs
$28.58 - $30.40
3% of jobs
$30.40 - $32.21
1% of jobs
$12
$20
$32
How much do quality and regulatory jobs pay per hour?
How does a Quality and Regulatory professional typically interact with other departments to ensure compliance and product quality?
What is a Quality and Regulatory professional?
What is the difference between Quality And Regulatory vs Quality Assurance Specialist?
| Aspect | Quality And Regulatory | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO, GMP, regulatory compliance certifications | ISO, Six Sigma, QA certifications |
| Work Environment | Regulatory agencies, compliance departments, manufacturing | Manufacturing, labs, product development |
| Employer & Industry Usage | Pharmaceuticals, biotech, medical devices | Manufacturing, consumer goods, tech |
Quality And Regulatory professionals focus on ensuring products meet regulatory standards and compliance requirements, often working closely with government agencies. Quality Assurance Specialists primarily focus on internal quality processes, testing, and product consistency. While both roles aim to ensure product quality, Quality And Regulatory roles emphasize compliance with external standards, whereas Quality Assurance Specialists concentrate on internal quality control.
What are the key skills and qualifications needed to thrive as a Quality and Regulatory professional, and why are they important?

Full-time
Re-posted 6 days ago
Job description
The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by maintaining compliance with domestic quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in supplying quality and regulatory input and feedback. Using prior education and work experience knowledge, helps assure compliance with overall regularity requirements, site, and UDI requirements.
RESPONSIBILITIES:
The duties & responsibilities of the QA/RA Manager include Regulatory Activities, Corporate Quality, oversight of Plant Quality, Microbiology/Sterilization and Document Control, but are not necessarily limited to the following responsibilities:
- Developing and maintaining quality and regulatory systems and system elements in conformity with domestic medical device agency regulations and requirements.
- Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing regulatory and quality activities, initiating, and executing audits (internal and external); determining system improvements; implementing change.
- Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Working knowledge of device and biologic frameworks Design Control and/or Quality by Design. Must be able to guide team through phases, understand documentation and testing requirements, and maintain files.
- Participating in the development and execution of installation, operational and performance qualifications of equipment, (IQ, OQ and PQ) including the clean room itself.
- Act as UDI information coordinator, including:
- Managing data within the UDI spreadsheet, including updates due to product changes
- Completing UDI system data entry throughout the product lifecycle (e.g., GUDID Label Data Entry User, EUDAMED)
- Responding to regulatory agency questions with support from the Quality/Regulatory Director
- Manage UDI system access (e.g., GUDID, EUDAMED)
- Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations (Med Con, ASQ, AAMI).
- Manages supplier controls through the Approved Supplier List (ASL) and conducts supplier audits.
Skills/Qualifications:
EDUCATION AND EXPERIENCE
- BS or BA degree in a life science, or similar with advanced experience in QA/RA areas or related training required
- 5 - 7 years' experience in QA and Regulatory Affairs Knowledge and direct working experience with ISO and FDA GMPs Regulations.
- Advanced training and certifications related to quality assurance a plus.
SKILLS, SPECIALIZED KNOWLEDGE AND ABILITIES
- Demonstrated success in leading and developing a collaborative team is essential.
- Ability to work with Government officials and FDA/ISO auditors.
- Effective project management skills, excellent interpersonal, verbal, and written communications skills.
- The ability to exercise authority, manage conflict, and influence others to a point of view in a positive way.
- Customer, team-focused, proactive, and seeks continuous improvement.
- Ability to remain calm and composed in stressful situations.
- Ability to work with and communicate well with other groups outside of QA/RA.
- Ability to lead meetings and small groups.
- Working knowledge of Microsoft Word, Excel, and Master Control or a Cloud based quality systems.
- Working knowledge of ERP & PLM systems
PERSONAL CHARACTERISTICS:
Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.
Creativity/Innovation: Develop new and unique ways to improve function efficiency and performance.
Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.