No more applications are being accepted for this job
- 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.
- Candidates seeking a project management role overseeing the entire regulatory process may be considered overqualified.
- 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.
- Strong IVDR experience
- Regulatory affairs expertise
- Independent yet collaborative work approach
- 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.
Regulatory Specialist - Scarborough, United States - INTELLECTT INC
Description
Role :
Regulatory Specialist II
Location :
Scarborough, ME
Duration : 06+ Months on W2 (Contract only)
Shift Timings : 8 am - 5 pm
Skills Looking For:
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.
Education and Level of Experience:
Top 3 Skills:
Interview Process: