Senior Regulatory Affairs Consultant

On behalf of my client, we are working with them on a new opportunity for a Senior Regulatory Affairs Consultant.  You will need to be a self-starter, capable of working independently and as part of our team.  You will be responsible for managing and coordinating activities necessary to ensure client company compliance with the requirements of EU medical device legislation (MDR 2017/745 and IVDR 2017/746).  

This is a permanent role on satisfactory completion of the initial 6 months probationary period.  It can be full or part time.  The candidate will be employed by the Dublin office and needs to be physically based in an EU country.  There can be a balance of remote working and office working, as preferred by the candidate.  If fully remote, periodic visits to the office, as appropriate, may be requested from time to time.

Major responsibilities:

• Development, implementation, and execution of proactive and pragmatic regulatory, clinical and compliance support strategies for medical devices, in-vitro diagnostics, and drug-device borderline / combination products on behalf of client companies.  Client companies range from small start-ups to medium enterprises.
• Evaluating classification and due diligence review of technical, preclinical, and clinical data for regulatory submissions.
• Development of EU MDR/IVDR technical documentation covering a wide range of medical technologies.
• Plan, manage, collate, submit (where necessary), and follow up Competent Authority (CA) and Notified Body (NB) submissions.  Maintain compliance of CE technical documentation aligned with device and process changes as per relevant regulatory requirements.
• Designing, planning, implementing, and delivering training on quality and risk management systems in accordance with EU requirements, including but not limited to MDR/IVDR, ISO13485, ISO9001, ISO14971.
• Networking and ongoing liaison with the CAs and Notified Bodies NBs in Europe.  Experience in other territories an advantage.

Desired Skills & Experience:

• Third level qualification in medicine, pharmacy, engineering, or another relevant science discipline.
• At least 10 years’ experience in an RA role within an ISO13485 EU regulated medical device environment.
• Substantial experience with and knowledge of the technical documentation elements to CE mark a medical device, IVD or combination product in Europe.
• Substantial experience in liaising with various relevant competent authorities / notified bodies in Europe.
• Demonstrable knowledge of ISO13485, and ISO14971 requirements.
• Some experience with drug-device combinations a distinct advantage.
• Must have the ability to communicate effectively with management and fellow peers.
• Pro-active and disciplined with proven ability to work under own initiative, and strong team player.
• The ability to establish priorities from among several demands and to handle interruptions effectively.
• Hands-on approach to work and good problem-solving abilities.
• Superb attention to detail and high level of accuracy in all aspects of the position.
• Works to the highest professional, ethical, and moral standards.

Package:

A generous remuneration package and flexible working conditions are available for all members of the team.

For full details contact Ciara at cphillips@thornshaw.com or call +353 1 2784671.

Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com