Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist
  • £50,000 - £65,000 per Annum
  • Permanent
  • Borehamwood, Hertfordshire, England, UK WD6 3SJ Borehamwood Hertfordshire UK WD6 3SJ
Job Ref: J35731
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 13 March 2020
Senior Regulatory Specialist - Global MedTech Manufacturer

Senior Regulatory Affairs Specialist - Permanent - North London

Key tasks

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Evaluates proposed products for regulatory classification and jurisdiction
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

Qualifications and skills

  • BS in Engineering, Science, or related degree; or MS in Regulatory Science
  • Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance; and distribution.


12/04/2020 12:37:13
GBP 50000 50000
Contact Consultant:
Molly Cooley

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