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Regulatory Affairs Specialist

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Emblation is a global leader in medical microwave technology, with a focus on radical innovation in the treatment of HPV infections, dermatology, cardiology, and oncology.

The team is led by some of the world’s foremost medical microwave experts, with a wealth of experience in the design, development and manufacture of microwave applications for a range of medical fields. Emblation is committed to providing next generation solutions for today’s medical conditions.

To support Emblation’s expansion and growth, we have a great opportunity for a new Regulatory Specialist role within our Regulatory & Quality team. You will mainly be responsible for supporting Medical Device regulatory submission and regulatory compliance activities.

Key tasks for position holder:

  • Compile regulatory submissions, Technical Files for new product and changes to existing products & markets.
  • Contribute within new product development projects to provide ongoing regulatory guidance and ensure compliance with relevant regulatory requirements.
  • Review labelling/marketing material for compliance with applicable regulations and standards.
  • Support post-market surveillance and vigilance activities, including submitting reports to authorities.
  • Review new and existing regulations, guidance documents & Standards, and prepare comments based on impact to product and business.
  • Provide regulatory and scientific advice to other areas of the Organization.
  • Develop regulatory affairs internal policies and procedures and provide training as and when required.
  • Review changes in manufacturing for regulatory effects and compliance with applicable regulations.
  • Participate in company regulatory/quality audits.
  • Reports to Director of Regulatory & Quality.

Experience required

  • Bachelor of Science Degree in biology or similar field, from an accredited college or university and a minimum of 2 years of Regulatory experience within a Medical Device or Pharmaceutical environment.
  • International regulatory affairs experience with awareness of EU MDD/MDR, FDA, Heath Canada and other regional regulations.
  • Excellent interpersonal, oral and written communication skills.
  • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Fluent in English.

Additional Information:

  • Driving license and ability for infrequent travel.
  • Must have unrestricted right to work in the UK.

Job Type: Full-time, Permanent