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Job Details

Regulatory Affairs Manager - Medical Device

Company: Umbilical Life
Location:
Reference: MD-112AB
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Avni Bhayani at Umbilical Life is recruiting a permanent experienced Medical Device Regulatory Affairs manager for an expanding company in London. The company is recognised as one of the world’s leaders in this sector! The business is a small and dynamic team and is expanding their business internationally.

Requirements:

Core Responsibilities

  • Deal with all aspects of registration and regulatory affairs of medical devices  
  • Advising Medial Device companies through the life-cycle of their product

Responsibilities

  • European and other country specific regulations
  • Organisation of database and application of registration
  • Renewal and variation where appropriate
  • Can work independently
  • Can use own initiative within a small team
  • Has experience of liaising with country-specific distributors and regulatory bodies
  • regulatory/clinical professional with specialized expertise in the regulation and clinical development of medical devices in European markets.
  • Working closely within a cross functional team to generate and execute the delivery of new products into new markets
  • Builds relationships and negotiates with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development

Experience

  • Experience with pharmacovigilance is essential
  • Involvement in contract development and manufacturing
  • Experience in medical devices Regulatory Affairs is essential 
  • Experience of compiling technical documentation for regulatory submissions, whilst      working to strict deadlines.

Apply for this job: Regulatory Affairs Manager - Medical Device

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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