MedTech Regulatory Affairs Specialist (ISO 13485, CE)

MedTech Regulatory Affairs Specialist (ISO 13485, CE)

Full-Time 63000 - 77000 Β£ / year (est.) No working from home possible
Newton Colmore Consulting

At a Glance

  • Tasks: Ensure regulatory compliance for medical devices across Europe, North America, and APAC.
  • Company: Join a growing team at Newton Colmore Consulting in the MedTech sector.
  • Benefits: Competitive salary and opportunities for professional growth in a dynamic field.
  • Other info: Exciting opportunity to work in a fast-paced environment with global reach.
  • Why this job: Shape strategies that impact healthcare innovation and improve patient outcomes.
  • Qualifications: 2-5 years in regulatory affairs with expertise in ISO 13485 and CE marking.

The predicted salary is between 63000 - 77000 Β£ per year.

Newton Colmore Consulting is seeking a Regulatory Affairs Specialist - MedTech in Cambridgeshire to join a growing medical devices team. You will oversee regulatory compliance across Europe, North America and APAC, shaping strategy and processes while ensuring design and manufacturing meet standards.

The ideal candidate will have 2–5 years of experience in regulatory affairs with a strong background in ISO 13485 and CE marking, and a technical degree in engineering or biomedical fields.

MedTech Regulatory Affairs Specialist (ISO 13485, CE) employer: Newton Colmore Consulting

Join a dynamic mechanical engineering services company that prioritises employee growth and development, offering clear progression pathways and a supportive work culture. With a focus on building long-term relationships and delivering exceptional service, you'll thrive in an environment that values your expertise and encourages innovation. Located centrally in Hampshire, this role provides the unique advantage of engaging with diverse industrial sectors across the South Coast, ensuring your contributions have a meaningful impact on the business's success.

Newton Colmore Consulting

Contact Details:

Newton Colmore Consulting Recruitment Team

We think you need these skills to ace MedTech Regulatory Affairs Specialist (ISO 13485, CE)

Regulatory Compliance
ISO 13485
CE Marking
Technical Degree in Engineering or Biomedical Fields
Experience in Regulatory Affairs
Strategic Planning
Process Development