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Regulatory Affairs Manager (full time) - global Medical Devices company - Zug

Job Title: Regulatory Affairs Manager (full time) - global Medical Devices company - Zug
Contract Type: Permanent
Location: Zug, Switzerland
Industry:
Salary: Competitive
Start Date: 2020-01-28
Reference: BH-122872-1
Contact Name: Martin Ivanov
Contact Email: Martin.Ivanov@nesgt.com
Job Published: January 28, 2020 15:39

Job Description

Regulatory Affairs Manager (full time) - global Medical Devices company - Zug

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.

Currently we support one of our clients in the Medical Device industry in Zug. In order to strengthen their team there, we are looking for an experienced professional to join them as the Regulatory Affairs manager for their global products. Their current and upcoming global projects in Q1 and Q2 predict growth in the RA department and they've reached to us for our support.


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, introduction and preparation for a successful application 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

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 devices, medical device, MDD, MDR, regulatory affairs, RA, manager, support, submissions, project management, CFR 820, ISO 13485