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Regulatory Affairs Consultant

Real Staffing
Job LocationWarwickshire
EducationNot Mentioned
Salary60,000 - 70,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

Regulatory Affairs Consultant - (Medical Devices)Our client, a rapidly growing medical device consultancy are looking for a Senior 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 medicaldevices into the EU. The Regulatory Consultant will report to the Managing Director.Position

  • To provide Medical Device Regulatory consultancy for UK/EU clients and prospective clients.
  • Support the Managing Director
  • Maintain clients CE Technical Files to ensure compliance to current regulations.
Key Responsibilities:
  • To provide accurate and current medical device regulatory and quality management advice to all our client base and prospective clients.
  • The Regulatory Affairs Consultant will prepare, review, and approve data elements for use in regulatory technical files in accordance with UK/EU requirements for medical devices.
  • CER writing
  • Development and writing of CE marking technical files & Knowledge of Clinical process.
  • Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
  • To perform visits to clients premises (or other location at clients request) to conduct regulatory/ quality meetings, audits, and any other relevant regulatory requirements.
  • Oversea regular communication with clients to provide accurate and concise updates on regulatory changes that could affect their businesses.
  • To ensure clients comply with the organisations ISO 13485 accreditation.
About You:
  • Ideally, a Scientific background.
  • Extensive regulatory experience within the medical devices sector.
  • Ideally knowledge of Class I, IIa, IIb and III EU technical documentation for CE marking, Clinical Evaluation compilation to current MEDDEV guidance and Risk Management implementation to medical device standard ISO 14971.
  • Ideally, knowledge of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971 and ISO 9001.
  • Internal/Supplier Auditing experience
To find out more about Real please visit www.realstaffing.comReal 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

Keyskills :
AuditClinicalMedical DevicesRegulatory AffairsMDRISO 13485MDDUKCAMDSAPIVDR

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