Senior Professional Customs & Trade Compliance
AUTODOC
Regulatory Affairs, Biological Safety Specialist
seleon GmbH
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Collaborate with R&D, Quality Management and Regulatory Affairs to ensure biocompatibility requirements are met
- Plan, conduct and document biological evaluations
- Prepare Biological Evaluation Plans and reports
- Communicate with external laboratories and coordinate test execution
- Develop, validate and document reprocessing instructions
- Monitor standards and regulatory changes
Requirements
- Degree in Biology, Biomedicine, Chemistry, Medical Engineering or comparable qualification
- Several years of professional experience in biological evaluation and reprocessing of medical devices
- Solid knowledge of the MDR (EU 2017/745), the ISO 10993 series, ISO 17664 and relevant standards/guidelines
- Experience collaborating with testing laboratories and in preparing technical documentation
- Business-fluent English, written and spoken
Benefits
- Attractive and flexible working hours
- Designated remote work (home office) days
- Contributions to an occupational pension scheme
- Subsidies for childcare expenses
- Company bicycle leasing
- Complimentary coffee and tea
- Regular quarterly breakfasts
- Team events and an annual company party
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biological evaluationreprocessing instructionstechnical documentationbiocompatibility requirementsbiological evaluation plansreport preparationregulatory compliance
Soft skills
collaborationcommunicationcoordination
Certifications
degree in Biologydegree in Biomedicinedegree in Chemistrydegree in Medical Engineering
