Regulatory Specialist

3 weeks ago


Scarborough, United States Intellectt Inc Full time

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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