W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9jbhnyzxnvdxjjaw5nig5ldy9qcgcvbmv3lwjhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Senior Regulatory Specialist (Software within Medical Devices)

  • Location

    Baden-Württemberg, Germany

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    110000

  • Contact:

    Cheikh Khoule

  • Contact email:

    cheikh.khoule@catalystcareers.com

  • Job ref:

    56021

  • Published:

    5 months ago

  • Expiry date:

    2021-04-24

  • Consultant:

    Cheikh Khoule

Vacancy Details

 

My client, a Global Medical devices company are looking for a Senior RA Specialist in Software Medical Devices based in South West Germany.

 

A great opportunity to join a fast-growing company with a great portfolio of products and clients.

 

Senior RA Specialist in Software Medical Devices

 

Location: South West Germany (home working can be flexible)

Salary: Up to 110,000€

Duration: Permanent

 

Global Medical devices company

 

Job function:

  • Compilation of tech files
  • Implementing QMS to ISO 134585 or MDSAP
  • Close interaction with international Notified Bodies and Competent Authorities
  • Setting up risk management
  • Right SOPs for QMS
  • Being responsible for leading projects

 

To be considered you need to have

  • Eligibility to work in Germany
  • 5+ years’ experience in medical devices industry
  • 5+ years’ experience in Regulatory Affairs
  • Profound knowledge in 62304 and MDSW CE marking
  • 510(k) experience (desirable)
  • English mandatory
  • German (desirable)
  • 60601 experience (desirable)

 

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV and the best time for a call to cheikh.khoule@catalystcareers.com to setup a confidential discussion about potential opportunities.

 

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

CLS offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

 

Catalyst Life Sciences

CLS are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets.

  • Pre-clinical Development & Safety
  • Clinical Development
  • Medical Affairs & Information
  • Regulatory Affairs
  • Pharmacovigilance/Drug Safety
  • Quality & Validation
  • Finance

 

My Linked In Profile

 

linkedin.com/in/cheikh-khoule

 

I personally specialise in recruiting QA, RA and validation professionals for roles across DACH so please do get in touch should you be considering new roles or looking to fill ones at your current company!

 

KEYWORDS

 

RA / regulatory / MDD / MDR / devices / 13485 / submission / regulatory / FDA / CFR / 21 / MDSAP / 62304 / project / manager / CE / marking / QMS / SOP / technical / files / documentation / Risk / medical / software