Regulatory Affairs Specialist Jobs in Lynn, MA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Quality Systems & Regulatory Affairs Specialist, Digital Health
- Boston, MA (9 miles from Lynn, MA)
- 1 hour ago
- Boston, MA (9 miles from Lynn, MA)
- 1 hour ago
Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements. Supports maintenance of the quality management system....
- Chelmsford, MA (22 miles from Lynn, MA)
- 2 days ago
- Chelmsford, MA (22 miles from Lynn, MA)
- 2 days ago
Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product...
Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred)
- Boston, MA (9 miles from Lynn, MA)
- 5 days ago
- Boston, MA (9 miles from Lynn, MA)
- 5 days ago
Job Purpose Summary The Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist position is responsible for preparing regulatory submissions and registration documentation, providing quality...
- Billerica, MA (16 miles from Lynn, MA)
- 5 days ago
- Billerica, MA (16 miles from Lynn, MA)
- 5 days ago
Work to handle inspection readiness, internal audit programs, external audits, compliance, customer complaints, and quality management reviews....
Remote IT Quality Assurance and Compliance, Analyst
- Boston, MA (9 miles from Lynn, MA)
- 6 days ago
- Boston, MA (9 miles from Lynn, MA)
- 6 days ago
Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring that...
Remote WorkRegulatory Affairs Specialist, Biologics
- Tewksbury, MA (17 miles from Lynn, MA)
- 8 days ago
- Tewksbury, MA (17 miles from Lynn, MA)
- 8 days ago
Experience with FDA 21 CFR 820, ISO 13485, and ISO 9001. Proficiency with Microsoft Office tools, eCTD software, Adobe Acrobat, and working knowledge of QMS systems....
Senior Regulatory Compliance Analyst
- Boston, MA (9 miles from Lynn, MA)
- 8 days ago
- Boston, MA (9 miles from Lynn, MA)
- 8 days ago
About Us Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique...
Regulatory Affairs Specialist I
- Boston, MA (9 miles from Lynn, MA)
- 8 days ago
- Boston, MA (9 miles from Lynn, MA)
- 8 days ago
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
Senior Specialist, Regulatory Affairs
- Andover, MA (17 miles from Lynn, MA)
- 8 days ago
- Andover, MA (17 miles from Lynn, MA)
- 8 days ago
audits as required Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules....
Senior Specialist - Regulatory Affairs
- Braintree, MA (18 miles from Lynn, MA)
- 9 days ago
- Braintree, MA (18 miles from Lynn, MA)
- 9 days ago
Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing to and implementing regulatory strategies for the Company with a focus on achieving compliance for all...
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Boston, MA (9 miles from Lynn, MA)
- 11 days ago
- Boston, MA (9 miles from Lynn, MA)
- 11 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote Work- Boston, MA (9 miles from Lynn, MA)
- 12 days ago
- Boston, MA (9 miles from Lynn, MA)
- 12 days ago
Compliance Analyst Job Title: Compliance Analyst Job Code: 6951CK Job Category: Compliance/Risk/Legal Job Type: Permanent Job Location: Boston - MA Date Posted: Mar 1 2023 Expires On: Mar 31 2023...
- Billerica, MA (16 miles from Lynn, MA)
- 13 days ago
- Billerica, MA (16 miles from Lynn, MA)
- 13 days ago
Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace...
Senior Regulatory Affairs Specialist
- Woburn, MA (11 miles from Lynn, MA)
- 20 days ago
- Woburn, MA (11 miles from Lynn, MA)
- 20 days ago
Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses, providing regulatory...
- Andover, MA (17 miles from Lynn, MA)
- 21 days ago
- Andover, MA (17 miles from Lynn, MA)
- 21 days ago
Who We Are Enel is a globally recognized leader in sustainable energy and is consistently named one of Fortune Magazine's "Companies that are Changing the World." It is also one of the largest and...
Demographic Data for Lynn, MA
Moving to Lynn, MA? Find some basic demographic data about Lynn, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lynn, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lynn, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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