Regulatory Engineer

Job Ref: J25414
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 12 February 2018
  • Nottingham, Nottinghamshire, England, UK
  • £45,000 - £60,000 per Annum
  • Chloe Pulo
  • 0161 868 2236

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Medical Device Regulatory Engineer - Permanent - Nottingham - £Competitive + Benefits

SRG are working with a world leading Medical Device organisation who are looking to grow their engineering team with a permanent Regulatory professional. This role is hands-on and so requires someone with 3+ Years experience who is comfortable working as the sole responsibility for regulatory standards and requirements.

Responsibilities;

The successful candidate will play a vital role within both new product introduction program teams and product Lifecycle support in the area of regulatory submissions, global standards compliance and design controls. The applicant will be part of a growing Engineering team focusing within active medical device products.

* Utilize expertise in global medical regulatory standards. Arrange and manage testing for both new product regulatory submissions to 60601 and similar standards*Utilize expertise in global wireless standards compliance to arrange and manage testing for both new product regulatory submissions to FCC and RED standards *Drafting of all technical documentation to obtain FDA 510k clearance and CE marking technical files*Ownership of risk assessments*Act as the Design Control manager within new product teams to execute plans according to committed timelines *Actively manage compliance risk*Maintain customer focus and product quality vigilance, including Quality Management System compliance

The role may require the applicant to travel, both within the UK and globally on occasion.

Requirements:

*Bachelors degree or equivalent in Electronic or Biomedical Engineering or other relevant subject*Minimum of 3 years' experience of preparing technical documentation for FDA 510k submissions, and ideally CE technical submissions, risk assessments to ISO 14971, medical device electrical safety testing to IEC 60601-1 and FCC/ RED wireless standards*Experience of working within design control processes and operating within quality systems like ISO 13485, FDA QSR and MDSAP*Experience of interacting with engineers, test houses, internal and regulatory affairs bodies, notified bodies and audit teams*Ability to communicate clearly and concisely at all levels of management

The ideal candidate will have:

*Experience with medical products which include biomedical/electrical devices*Documentation with EN62304 for medical products (or similar industry quality standards)

If interested please send an updated CV or call 0161 868 2236 for more information.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.