Senior Regulatory Affairs Specialist (FDA experience mandatory)

• International company
  
  • Medical devices

About Our Client

Our client is an international company specialized in medical devices.

Job Description

• Provide Regulatory strategies for projects as RA representative in cross-functional teams
• Responsible for regulatory Assessment on product changes
• Coordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements)in the context of new product and product changes in accordance with FDA requirements
• Coordinate the responses to questions raised by FDA
• Review of product labelling
• Participate in audits and inspections, ensuring compliance with FDA requirements
• Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide strategic regulatory guidance to internal stakeholders
• Ensure accurate population of RA databases
• Maintain and update SOP's for Regulatory department

The Successful Applicant

• Minimum 7 to 10 years of experience in Medical device or pharmaceuticals industry
• Proficient knowledge of quality standard (ISO 13485) and relevant regulations (21CFR part 820, MDR 2017/745) and appropriate laws, guidelines and industry standards Demonstrated experience in communicating with regulatory agencies including FDA and UE regulatory agencies
• Demonstrated experience in leading, writing and submission of complex regulatory filling(e.g. IDE, PMA, CE mark, etc-)
• Demonstrated ability in analytical reasoning and critical thinking skills
• Good knowledge of relevant regulations (FDA)
• Ability to work on several projects simultaneously, ability to prioritize
• Fluent in English with at least a B2 level in French

What's on Offer

Great opportunity to join an amazing team and take the lead on challenging projects.

Contact

Sidonie Newton

Quote job ref

JN-042024-6389332

Job Function

Healthcare & Life Sciences

Specialisation

Regulatory Affairs

Industry

Healthcare / Pharmaceutical

Location

Geneva

Contract Type

Permanent

Consultant name

Sidonie Newton

Job Reference

JN-042024-6389332

Job Nature

Home Office