Medical Device Compliance Engineer

2 days ago


Chelmsford, Essex, United Kingdom Arevna Full time
About the Opportunity

We are looking for a highly skilled Graduate Regulatory Engineer to join our team at Arevna.

This is an excellent opportunity for a recent graduate to begin their career in the medical devices industry.

As a Graduate Regulatory Engineer, you will be responsible for ensuring compliance with international regulatory standards while supporting the development of innovative medical devices.

The estimated salary range for this position is £35,000 - £50,000 per annum.

You will collaborate closely with experienced professionals and cross-functional teams to deliver safe and efficient products to market.

Main Responsibilities:

  1. Prepare and submit regulatory documents for global approval (e.g., 510(k), CE marking).
  2. Develop and maintain Quality Management Systems (QMS) compliant with ISO 13485 and FDA regulations.
  3. Participate in risk management activities, including dFMEA and pFMEA processes.
  4. Maintain documentation to ensure compliance with regulatory and quality standards throughout the product lifecycle.
  5. Collaborate with R&D, quality assurance, and manufacturing teams on compliance and process improvements.

Essential Requirements:

  • A degree in Biomedical Engineering, Mechanical Engineering, or a related field.
  • Excellent analytical and problem-solving skills.
  • Interest in regulatory frameworks and quality assurance within the medical device industry.
  • Strong communication and teamwork skills.
  • Prior experience in the medical device sector is beneficial but not necessary.

Benefits:

  • Extensive training and mentorship to enhance regulatory knowledge.
  • A supportive and collaborative work environment.
  • The opportunity to contribute to innovative products improving patient outcomes.
  • A clear path for professional growth within the medical device industry.


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