W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9jbhnyzxnvdxjjaw5nig5ldy9qcgcvbmv3lwjhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Regulatory Affairs Lead

  • Location

    Berlin, Germany

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    na

  • Contact:

    Hannah Hughes

  • Contact email:

    hannah.hughes@catalystcareers.com

  • Job ref:

    61504

  • Published:

    16 days ago

  • Expiry date:

    2021-10-14

I am currently recruiting for a Senior Regulatory position for a pioneering MedTech diagnostics company based in East Germany. You'll be joining a fast-growing team working with innovative technology that has widespread impact for its users.

You'll be:
- developing regulatory plans and strategies to achieve approval in Germany, EU and internationally.
- writing, reviewing and editing technical documentation.
- optimising of regulatory processes within the quality system.
- interaction with third party and governmental regulatory agencies.
- instrumental in building and implementing a document management system.

The ideal candidate will have:
 - 5+ years' experience in quality management and regulatory affairs.
- excellent knowledge of regulatory standards and legal requirements (ISO 13485/IVDR/MDR/ MPG/FDA) for product. classification/qualification.
- MSc or BSc in engineering, medicine, life sciences subject.
- good knowledge of German and English language.

If interested, please get in touch by sending your CV to hannah.hughes@catalystcareers.com. I look forward to hearing from you.

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 to Hannah.hughes@catalystcareers.com for 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;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical Information
  • Medical Writers
  • Medical Affairs
  • Compliance
  • Audit
  • Validation
  • Production
  • Manufacturing
  • Clinical Trials
  • Clinical Research
  • Project Management
  • Finance

My Linked In Profile

https://www.linkedin.com/in/hannah-hughes-quality-and-regulatory-

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

KEYWORDS

Regulatory / RA / technical files / QMS / MDR / MDD / IVDD / IVDR /