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Regulatory Affairs Manager in Medical Devices - global Medical Device company

Job title: Regulatory Affairs Manager in Medical Devices - global Medical Device company
Contract Type: Permanent
Location: Basel
Industry:
Salary: Competitive
Reference: BH-122869-1
Contact Name: Martin Ivanov
Phone Number: +41 (0)43 588 16 16
Job Published: 14 days ago

Job Description

Regulatory Affairs Manager in Medical Devices - global Medical Device company

NES Global Talent in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise our clients through all recruitment rotes on a daily basis.

Within our range of clients we support big and small players in the industry who are leading organisations that manufacture products for the local and global markets. A client of ours that has upcoming projects in Q3 and Q4 predict growth in their Regulatory department and they've reached to us for our support. In order to strengthen their departments we are looking for a Regulatory Affairs Manager to join their teams.

Responsibilities:

  • Technical documentation handling according to specific international laws and guided documents (medical devices)
  • Establishment and maintenance of technical documentation and international registration documentation (STED/CSDT)
  • Responsibility with the establishment of conformity assessment (ER-Checklist) and draft issuance of the Declaration of Conformity
  • Establishment and maintenance of the Regulatory Process related documentation within the product lifecycle and review and release of marketing materials and labelling
  • Support the establishment, maintenance and optimization of Regulatory Affairs owned or relevant processes and process related documents
  • Actively consult and support teams thorough the product lifecycle with products safety licensing, standards and guided documents, risk management
  • Support of product development projects and change control activities such as testing (standards IEC 60601-1, environmental and packaging testing, sterilization, EMC, biocompatibility)
  • Compilation and implementation of the relevant registration documentation with cooperation with a responsible person or specific authorities (worldwide)

Requirements:
  • BSc or MSc in Life Science studies, or a corresponding industry experience
  • Experience in CFR 820, MDD, MDR, ISO 13485 (international country specific laws are a plus)
  • 2-3 years of experience in RA (International products/markets) in Medical Device/Technology field
  • Fluency in English, German and other languages are a plus

What to expect:
  • Detailed conversation and introduction to all roles and clients with an experienced consultant
  • Transparency and support throughout the application process
  • Negotiation with clients for better work/contract conditions
  • Follow up and update on market relevant opportunities

Notes: The responsibilities may differ depending on our clients’ needs

Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.

For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland.

Keywords: medical device, global projects, management, MDR, MDD, medical devices, Quality, Regualtory Affairs, Regulatory, CAPA, CAPAs, Quality Management System, Quality Management Systems, QMS, ISO 9001,  ISO 13485, FDA, QSR

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