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Regulatroy Affairs Specialist

Experis AG

Posted on Nov 24, 2021 by Experis AG

Zuchwil, Solothurn, Switzerland
21 Dec 0006
Annual Salary

Regulatory Affairs Specialist

  • Start date: ASAP/06.12.2021
  • End date: 12-month contract
  • Extension: possible
  • Workplace: Zuchwil
  • Workload: 100%


Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to European Council Directive 92/42/EEC or Regulation 2017/745, as applicable and US FDA 510(k) submissions or Notes to file, as applicable, As well as country registrations on a world-wide basis, as appropriate. In the context of Life Cycle Management projects (eg change of manufacturing process and/or equipment, change of manufacturing site, etc).

Position duties & Responsibilities:

  • Ensuring that the company's products comply with the regulations set up by government agencies
  • Advising engineering and other support functions, as well as manufacturing on regulatory requirements
  • Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
  • Creating, reviewing and maintaining regulatory related technical documentation
  • Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
  • Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale
  • Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials
  • Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
  • Providing progress of work-plans and the status of key project deliverables
  • Follow the applicable quality standards and regulatory requirements
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all time
  • Resolving complex issues as they arise

Must haves:

  • 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • Strong knowledge of
    • ISO 13485 and ISO 9001, QSR
    • Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
    • MEDDEV guidance documents applicable to Medical Devices products and processes
  • Reasonable knowledge of
    • FDA requirements
    • Registration requirements in further global markets would be an asset
  • Strong understanding of Risk Management process, label and labeling, change management is desired
  • International experience preferred
  • Proven exceptional written and oral communication skills

Educational Requirements:

  • Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.

Other requirements:

  • Familiarity with Technical Documentation structure according to STED required
  • Strong knowledge and skills in MS Office
  • Teamwork oriented, within a multi-functional and multi-national team
  • Strong interpersonal and diplomatic skills
  • Customer/service orientation
  • High analytical, planning and organizational skills; able to set priorities
  • Able to work on multiple simultaneous tasks with limited supervision
  • Quick learner, motivated self-starter
  • Excellent customer service, interpersonal, communication and team collaboration skills
  • Able to cope with internal guidelines change management
  • Some flexibility in working hours is required
  • English spoken and written & German would be a plus

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Alex Russell.

Reference: 1409122839

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