Medical Device Compliance Engineer
2 days ago
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:
- Prepare and submit regulatory documents for global approval (e.g., 510(k), CE marking).
- Develop and maintain Quality Management Systems (QMS) compliant with ISO 13485 and FDA regulations.
- Participate in risk management activities, including dFMEA and pFMEA processes.
- Maintain documentation to ensure compliance with regulatory and quality standards throughout the product lifecycle.
- 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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