Regulatory Affairs Consultant - Warwickshire, United Kingdom - Real Staffing

Real Staffing
Real Staffing
Verified Company
Warwickshire, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Our client, a rapidly growing medical device consultancy are looking for a Regulatory Affairs Consultant to join their team. They provide consulting services to start-ups and small to medium
- sized medical device manufacturers seeking to import medical devicesinto the EU. The Regulatory Affairs Consultant will report to the Managing Director of the business and gain exposure to a variety of projects and marquee medical device clients. This is a permanent position offering fully remote working set up.


Role:


  • The Regulatory Affairs Consultant will provide Medical Device Regulatory consultancy for clients and prospective clients
  • Support the Directors and mentor junior staff as required
  • Maintain clients CE Technical Files to ensure compliance to current regulations

Responsibilities:


  • Provide accurate and current medical device regulatory and quality management advice to all our client base and prospective clients
  • Prepare, review, and approve data elements for use in regulatory technical files in accordance with UK/EU/US requirements for medical devices and IVD's
  • CER writing
  • Development and writing of CE marking technical files & Knowledge of clinical process
  • The Regulatory Affairs Consultant will communicate with external regulatory authorities to ensure approvals are obtained in line with project schedules
  • Perform visits to clients' premises (or other location at client's request) to conduct regulatory or compliance meetings, audits, and any other relevant regulatory requirements
  • Oversee communication with clients to provide accurate and concise updates on regulatory changes that could affect their businesses
  • Ensure clients comply with the organisation's ISO 13485 accreditation

About You:


  • Ideally, a Scientific background OR relevant practical experience
  • Regulatory experience within the medical devices sector OR life sciences
  • Ideally knowledge of EU technical documentation for CE marking with 510k file compilation and submission to FDA; in particular, Clinical Evaluation compilation to current regulations and standards
  • Ideally, knowledge of working to the appropriate quality and regulatory standards e.g., ISO 13485, ISO 14971, IVD 98/79/EC/IVDR and knowledge of MDSAP
  • Knowledge of electrical and software safety standards is desirable but not a deal breaker
  • Auditing experience
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales
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