Job Description
Job Description
Our client, a leading organization in the medical device industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs department supporting compliance activities across domestic and international markets. The ideal candidate will demonstrate strong analytical skills, effective communication, and a proactive approach, which will align successfully in the organization.
Job Title: Regulatory Affairs Specialist
Location: Merrimack, NH
What's the Job?
- Manage internal, domestic, and international compliance activities for medical devices.
- Develop comprehensive regulatory strategies for new devices and post-market changes.
- Prepare and review regulatory filings such as 510(k), PMA, EU MDR, and other international submissions.
- Negotiate directly with regulatory enforcement entities and communicate strategies to management and project teams.
- Support engineering changes and ensure documentation compliance with global regulations and standards.
What's Needed?
- Bachelor’s Degree in a related field.
- Minimum of four years of experience in Regulatory Affairs within a medical device environment, or ten years of related experience.
- Experience with regulatory submissions and approvals, including 510(k) or PMA.
- Knowledge of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR, and ISO 13485 standards.
- Proficiency in MS Office applications (Word, Excel).
What's in it for me?
- Opportunity to work in a dynamic and innovative environment.
- Engage in meaningful projects that impact global health and safety.
- Collaborate with a diverse and talented team of professionals.
- Develop your career with a company committed to compliance and excellence.
- Participate in internal and third-party audits, enhancing your expertise.
Upon completion of waiting period associates are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Supplemental Life Insurance
- Short Term Disability Insurance
- 401(k)
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.