Regulatory Affairs Specialist

3 days ago

Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time
Join Our Team as a Senior Regulatory Affairs Specialist

Welland Medical Ltd is a leading company in the healthcare industry, and we're seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.

About the Role:

  • Develop and implement regulatory strategies for new product development and registrations.
  • Manage the upkeep of all regulatory documentation and ensure compliance with relevant regulations and standards.
  • Lead a regulatory team of two, ensuring compliance across the business.
  • Collaborate with regulatory authorities to achieve successful product registrations.
  • Develop and implement regulatory strategies for New Product Development (NPD) projects.
  • Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
  • Provide regulatory support for sales and commercial activities.
  • Lead interactions with Notified Bodies on regulatory affairs matters.
  • Support all communications with regulatory authorities.
  • Lead regulatory transition projects and other significant regulatory initiatives.

Requirements:

  • Bachelor's degree (or equivalent) in a scientific, engineering, legal, or regulatory discipline.
  • Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency.
  • Proven experience with medical device technical files and EU MDD/MDR requirements.
  • Current specialist knowledge of medical device regulatory requirements in the EU and UK.
  • Experience working within a Quality Management System certified to EN ISO.
  • Additional qualifications in the field of medical device regulatory affairs.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

How to Apply:

Please submit your application, including your resume and a cover letter, to [insert contact information].

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