Regulatory Affairs Specialist Jobs in Devens, 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.
- Chelmsford, MA (13 miles from Devens, MA)
- 3 days ago
- Chelmsford, MA (13 miles from Devens, MA)
- 3 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...
- Billerica, MA (18 miles from Devens, MA)
- 5 days ago
- Billerica, MA (18 miles from Devens, MA)
- 5 days ago
Work to handle inspection readiness, internal audit programs, external audits, compliance, customer complaints, and quality management reviews....
Regulatory Affairs Specialist II
- Merrimack, NH (22 miles from Devens, MA)
- 6 days ago
- Merrimack, NH (22 miles from Devens, MA)
- 6 days ago
Requires skills and experience in the following: Working knowledge of ISO 13485 Medical device standards, EU MDD, EU MDR, and 21 CFR 820....
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (20 miles from Devens, MA)
- 8 days ago
- Tewksbury, MA (20 miles from Devens, 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 Specialist, Regulatory Affairs
- Andover, MA (24 miles from Devens, MA)
- 8 days ago
- Andover, MA (24 miles from Devens, MA)
- 8 days ago
audits as required Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules....
- Billerica, MA (18 miles from Devens, MA)
- 13 days ago
- Billerica, MA (18 miles from Devens, 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...
- Worcester, MA (21 miles from Devens, MA)
- 18 days ago
- Worcester, MA (21 miles from Devens, MA)
- 18 days ago
Compliance Analyst Worcester, MA, USA Req #18642 Monday, February 24, 2025 For more than 170 years, The Hanover has been committed to delivering on our promises and being there when it matters the...
Senior Regulatory Affairs Specialist
- Woburn, MA (23 miles from Devens, MA)
- 20 days ago
- Woburn, MA (23 miles from Devens, 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 (24 miles from Devens, MA)
- 21 days ago
- Andover, MA (24 miles from Devens, 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...
Principal Regulatory Affairs Specialist, Digital Technology
- Lexington, MA (20 miles from Devens, MA)
- 22 days ago
- Lexington, MA (20 miles from Devens, MA)
- 22 days ago
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions,...
Risk Compliance Analyst Massbay Community College
- Ashland, MA (20 miles from Devens, MA)
- 30+ days ago
- Ashland, MA (20 miles from Devens, MA)
- 30+ days ago
Risk Compliance Analyst Department: VP Finance Location: Hybrid - remote & on-site MassBay fosters educational excellence and academic success to prepare students for local and global citizenship,...
- Bedford, MA (17 miles from Devens, MA)
- 30+ days ago
- Bedford, MA (17 miles from Devens, MA)
- 30+ days ago
Regulatory Affairs Specialist Responsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation....
Senior IT Risk & Compliance Analyst - Remote Available
- Framingham, MA (17 miles from Devens, MA)
- 30+ days ago
- Framingham, MA (17 miles from Devens, MA)
- 30+ days ago
Discovery is at the heart of everything we do. Wherever you find us around the world, if you can think of a product, you can probably find it in our stores, which include TJ Maxx, Marshalls,...
Remote WorkRegulatory Affairs Specialist III
- Waltham, MA (20 miles from Devens, MA)
- 30+ days ago
- Waltham, MA (20 miles from Devens, MA)
- 30+ days ago
LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Regulatory Affairs Specialist III HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Provide Regulatory Affairs support to GSD project teams and...
Remote WorkSenior Specialist, Regulatory Affairs - Remote
- Westborough, MA (18 miles from Devens, MA)
- 30+ days ago
- Westborough, MA (18 miles from Devens, MA)
- 30+ days ago
Working Location: NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making peoples lives healthier, safer and more fulfilling. Every day, we live by our...
Demographic Data for Devens, MA
Moving to Devens, MA? Find some basic demographic data about Devens, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Devens, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Devens, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- Corrective Actions & Preventive Actions
- 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
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »