Regulatory Specialist
3 weeks ago
Role: Regulatory Specialist II
Location: Scarborough, ME - 04074
Duration: 06+ Months on W2 (Contract only)
Shift Timings: 8 am - 5 pm
Skills Looking For:
- The project entails a regulatory affairs specialist position focusing on IVDR compliance for European regulations.
- Strong IVDR (In Vitro Diagnostic Regulation) experience is required.
- Regulatory affairs expertise, ideally with four plus years of experience.
- Familiarity with European regulations and strong technical writing skills.
Day-to-day Responsibilities: Compiling and submitting regulatory documents to health authorities; Interacting with various departments for document compilation and submission; Independent work on regulatory tasks while also collaborating cross-functionally.
- Candidates seeking a project management role overseeing the entire regulatory process may be considered overqualified.
Education and Level of Experience:
- Bachelor's degree required, preferably with a background in biology, chemistry, or a related scientific field.
- Four plus years of regulatory affairs experience, with specific emphasis on IVDR.
- 2 to 3 years of IVDR regulatory experience is also fine but must have an overall 4 years of regulatory experience.
Top 3 Skills:
- Strong IVDR experience
- Regulatory affairs expertise
- Independent yet collaborative work approach
Interview Process:
- 2 to 3 rounds of interviews.
- First round will be onsite with the manager and next two rounds will be virtual with other team members.
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