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Jr. Regulatory Affairs Specialist

Switzerland   •  Contract/Temporary, Full time

QLS are recruiting for a Jnr Regulatory Affairs Specialist to join an important project with a global Medical Device Company at their site based in Zuchwil on a contract basis until the end of the year.

The main purpose of the role will be to:

  • Support the internal 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,
    • US FDA 510(k) submissions or Note to files, as applicable,
    • As well as country registrations on a world-wide basis, as appropriate

  • Ensure that the company\'s products comply with the regulations set up by government agencies
  • Advise engineering and other support functions, as well as manufacturing on regulatory requirements
  • Assist 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
  • Create, review and maintain regulatory related technical documentation
  • Support 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
  • Capture and verify regulatory product characteristics to support logistic and supply chain efforts on a global scale
  • Work 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

Further responsibilities will include:

  • 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 times
  • Resolving complex issues as they arise

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • 1-2 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • 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
    • 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
  • 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.
  • Familiarity with Technical Documentation structure according to STED required
  • Team work 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
  • Strong knowledge and skills in MS Office
  • English spoken and written required, German would be a plus

Please could you send any correspondence in English. Please quote reference QLS 00051036 in all correspondence.

You MUST be eligible to work in Switzerland. Learn more

  • Agency: CK Group
  • Contact: Adrien Guimard
  • Phone: 01438 723 500
  • Reference: 51036
  • Posted: 30th June 2021
  • Expires: 28th July 2021

CK Group

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