To be based in the UK: Cambridge, or Epsom
Who we are
Science Group provides independent advisory and advanced product development services focused on science and technology initiatives. We operate at the cutting edge of science and innovation, supporting our clients under five specialist brands: Sagentia, Oakland Innovation, OTM Consulting, Leatherhead Food Research and TSG Consulting.
We have a global reach with a multinational and multicultural workforce spanning the U.K., Europe, and North America that fuels our success. Whether one of our scientists, engineers, regulatory advisors, market-experts, or central support staff, we look for exceptional hands-on employees that will flourish in a dynamic and stimulating environment.
TSG is seeking a Principal Consultant in Medical Regulatory Affairs to lead consulting services to the Medical Device Industry. The successful individual must be able to take the lead role in Regulatory Affairs consulting projects, providing leadership to a multi-disciplinary team supporting the preparation and submission of regulatory dossiers as part of FDA and EU CE approvals.
- Advise clients on Regulatory strategy
- Work with team members to manage the preparation of documents for submission to regulatory agencies in the US, EU, and other geographic regions.
- Responsible for providing leadership assessment of the US and EU regulation for drug/device combination products for market approval and commercialization.
- Responsible for project timelines and management of multiple regulatory submissions for respective Clients including authoring and preparing pre-submissions, 510(k), IDE, PMA in compliance with the FDA, and EU regulations and guidelines.
- Provide leadership in regulatory assessments for Client’s anticipated design, manufacturing, and labeling changes.
- Perform regulatory research and stay abreast of changes in the agencies regulations and requirements.
- Provide regulatory support for regulatory compliance activities as required.
- Lead interactions with the FDA and European Notified Bodies
- Build relationships and a business stream with new accounts
You will bring a detailed understanding of Medical Device/IVD Regulatory affairs with knowledge of both the FDA and EU regulatory framework. You will have experience of obtaining market approval in both jurisdictions through submissions of 510(k), IDE, PMAs and CE Technical Files. You will have experience of defining regulatory strategies and supporting companies through the whole process from early stage product development through approvals and post-market surveillance and compliance.
Experience & qualifications
- A degree in science or engineering.
- Proven track record of consulting experience in Medical Regulatory Affairs.
- Proven track record of leading pre-market approval submissions in USA and/or EU.
- Established knowledge of FDA regulations including PMA, IDE, 510(k), Quality Systems, cGMP’s, labeling, advertising/promotion.
- Experience with successful regulatory submissions in the US (510(k)/IDE/PMA) and EU along with regulatory review of supportive clinical trials data.
- Ability to demonstrate a self-motivated, highly organized and innovative approach to work.
- Current knowledge of the regulatory landscape and workings of the regulatory bodies.
- Experience design of regulatory strategies for innovative medical device development.
- Must be a team builder with good written and verbal communication skills.