Project 55196 – Regulatory affairs specialist – US submission



pharmatch

JOB DESCRIPTION

Contract Type

Candidate (Freelancer)

Company Type

Medtech

Company Size

Middle 1000 – 5000


Requested Expertise

Regulatory Affairs / /

Profile Required

Experience bringing a MD to US market
Fluent in english
5 to 10 years experience minimum
MD/PharmD background

Project Description

Our client, a company based in Switzerland, is looking for a senior regulatory affairs specialist to support the local RA team for a Medical device US submission and launch.

The responsibilities include:
– Identify the applicable regulations and guidelines for US compliance and registration
– Strategic planning of the RA activities for this MD
– Prepare the regulatory documentation for the submission (creation, review..)
– Support key relationships and follow-up with regulatory authorities
– Ensure the compliance with the relevant regulations
– Collaborate closely with product development, marketing and sales teams.

Therapeutic Area

Diabetes

Language

English

Hard Skills

Soft Skills

Seniority Level

Experience 5 – 10 years


Starting Date

2024-03-04

Project Duration

4 months

FTE / nb of days per week

5

Project Location

Basel, Switzerland

Remote Flexibility

Yes

Travel Expected

No

Approximative Budget

Any other information of interest

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