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Job Details

Head of Regulatory Affairs - Small Niche Biotech - Paris

Company: Just Pharma
Location: France
Reference: BBBH3535
Closing Date: 16 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Head of Regulatory Affairs - Small Niche Biotech - Paris JustPharma are working alongside a Small Niche Biotechnology company who are looking to recruit a Head of Regualatory Affairs to join their expanding teams.This person will be responsible for designing, managing and executing the company’s regulatory strategy, ensuring that the company meets applicable medical device legislations and ensuring that the company’s products meet all applicable regulatory requirements. ...

Requirements:

Head of Regulatory Affairs - Small Niche Biotech - Paris

JustPharma are working alongside a Small Niche Biotechnology company who are looking to recruit a Head of Regualatory Affairs to join their expanding teams.

This person will be responsible for designing, managing and executing the company’s regulatory strategy, ensuring that the company meets applicable medical device legislations and ensuring that the company’s products meet all applicable regulatory requirements.

Duties & Responsibilities

- Propose and execute regulatory approval strategies, including preparation and maintenance of all regulatory submissions.

- Design, draft, and lead regulatory filing submissions to various international competent authorities.

- Lead and execute the communication with competent authorities including preparation of technical dossiers for pre-submission meetings, submissions, reports and responses to questions and inquiries.

- Perform on a continuous basis the regulatory watch in the applicable jurisdictions and act accordingly to ensure continuous compliance to applicable



Job Environment/Interactions

- Work closely with their Innovation Hub & Development Factory teams, especially the QA

- Work closely and build relationship with their parters

- Develop an effective worldwide regulatory Strategy with clear recommendations to their Management.

Qualifications and Skills

- Engineering Degree or equivalent

- Five (5) to ten (10) years of regulatory affairs experience in the medical device industry, with at least five (5) years of experience in class III medical devices

- Excellent communication skills (written and verbal) in English and at least one other European Language preferably French

- Proven experience in preparing and reviewing submission packages and interaction with EU notified bodies and the FDA

- An in-depth understanding of various standards and associated requirements including ISO 13485, ISO 14971, and ISO 13408



This client are going through a very exciting time at the moment, recently having FDA approval for Clinical trials which means they are looking to grow their teams.

Please send through a CV if you would like to find out more about the client - or call me on 00441707802963





Regulatory Affairs, Regs, Reg affairs, FDA, Medical Device, Medical devices, Biotechnology, 13485 14971, 13408, ISO, Class III , Head, France, Paris, French

Apply for this job: Head of Regulatory Affairs - Small Niche Biotech - Paris

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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