Regulatory Affairs Sepcialist

Eindhoven

Netherlands

ā‚¬650.00/year

Contract

Medical & Regulatory Affairs

1

We are seeking an experienced Regulatory Affairs (RA) Consultant to support regulatory activities for a Class IIa medical device.

Responsibilities:

  • Oversee post-market regulatory compliance for Class IIa devices.
  • Develop, review, and update technical documentation.
  • Ensure adherence to IEC 62304 (Medical device software lifecycle) and IEC 60601 (Medical electrical safety standards).
  • Provide guidance on compliance with EU MDR and FDA regulations.

Requirements:

  • Proven experience in medical device regulatory affairs.
  • Strong knowledge of IEC 62304 and IEC 60601.
  • Familiarity with EU MDR and FDA requirements.
  • Ability to manage and maintain technical files.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

Greg King

To Apply for this Job Click Here

Greg King

Submit Your CV

Name_1
Max. file size: 512 MB.

UPLOAD CV WITH:

This field is for validation purposes and should be left unchanged.

or Upload CV with

Similar Jobs

1

Contract

AWS Glue Data Engineer

Technology

Data Engineering and Streaming

Are you passionate about big data, automation, and logging systems? We are seeking a talented AWS Glue Data Platform Engineer to lead our Central See more…

to ā‚¬85.00/hour

Den Haag

Netherlands

1

Contract

SAP FICO Lead – Located in Netherlands

Technology

SAP

Darwin Recruitment are partnered with a global leader in Pharmaceutical industry and recruiting for a SAP FICO Consultant to work on multiple projects. Location: See more…

to ā‚¬120/hour

Nederland

1

Contract

HSE Specialist

Life Sciences

Other

Conduct EH&S risk evaluations as part of the Management of Change process, ensuring adherence to safety and environmental requirements. Ā· Implement best practices and See more…

to $1.00/year

Raleigh

USA