Regulatory Affairs Manager at KRecruiting Life Sciences
Berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

15 Jan, 27

Salary

1650000.0

Posted On

17 Oct, 26

Experience

15 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Medical Practices & Clinics

Description

Key Responsibilities

  • Prepare and review technical and regulatory documentation for international markets, including the EU, US and Australia.
  • Ensure compliance with applicable regulations for medical devices, detergents and disinfectants.
  • Support regulatory submissions and approval processes, including EU, FDA and TGA requirements.
  • Assess and implement requirements under REACH, CLP and the Biocidal Products Regulation (BPR), including relevant ECHA procedures.
  • Review product labelling, packaging and Safety Data Sheets (SDS).
  • Support quality management, risk management and cross-functional collaboration with R&D, Quality and Manufacturing teams.


  • RequirementsDegree in Chemistry, Pharmacy, Microbiology or a related scientific field.
  • Several years of experience in Regulatory Affairs, ideally with chemical cleaning and disinfection products for medical applications.
  • Strong knowledge of international regulatory requirements, particularly REACH, CLP and BPR.
  • Experience preparing technical documentation and regulatory submissions for international markets.
  • Excellent English skills and strong communication and project management capabilities.


  • Project DetailsStart: ASAP
  • Duration: Until End of March 2027
  • Workload: Initially up to 20 hours/week, expected to decrease to 10–15 hours/week
  • Location: 100% remote, worldwide


Responsibilities
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