Seeking Regulatory Affairs Specialist with Medical Device Experience
Seeking candidate with EU, MDR and 510K submission experience.
About Our Client
Our client is medical manufacturer in the Greater Boston Area and the leader in medical imaging technology.
This role will focus on supporting US and EU submissions for innovative products in addition to the following:
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans.
- Author and oversee documentation packages for submission to global regulatory agencies.
- Track timelines and document milestone achievements for inclusion in regulatory submissions.
- Interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE's, PMA's, annual reports, STED's and CE marking design dossiers and technical files)
- Monitor proposed and current US and EU regulations and guidance. Advise the impact of such regulations and guidance on the company within scope.
- Review regulatory content for claims support of promotional material, labeling content, product and process changes, and product documentation.
- Collaborate with cross-functional teams, and take direction from Regulatory Affairs team leaders.
- Develop, review and support maintenance of regulatory SOPs
- Support additional projects as assigned (e.g. MDR transition)
The Successful Applicant
Candidate should have the following skills for this role:
- 3-5 years experience in Regulatory
- Medical Device Experience REQUIRED. Harware/software background a plus.
- Experience with 510K submissions
- Domestic and International regulatory experience
- Be a team player and open to working in a startup environment
- Engineering Degree preferred. Bachelors Required.
What's on Offer
- Great Benefits
- Competitive Salary
- Growth opportunity
- Opportunity to work for a company with innovative technology