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Director Regulatory Affairs, EMEA

Apply now Job no: 613130
Work type: Permanent
Location: Addlestone, Basel, Gothenburg, Hannover, Mechelen
Categories: Quality & Regulatory, Western Europe, Eastern Europe, People Manager

Your responsibilities will include- 

Regulatory Strategy and Plans

  • Contribute to the development of corporate regulatory strategies in collaboration with corporate functions (CLTD, CBAS and CTC) taking marketing, clinical and reimbursement needs in EMEA into account
  • Develop EMEA regulatory plan in close cooperation with EMEA functions and country organisations in order to achieve timely regulatory approval (CE-Mark) and registration of products in each of the EMEA markets

Representative vis-a-vis Notified Bodies, National Competent Authorities in the EU and Ministries of Health in non EU-Member States

  • Act as primary contact to Cochlear’s Notified Bodies (NB) in EMEA
  • Review submissions for CE-Mark to ensure the submissions are compliant with EMEA requirements

Regulatory Intelligence

  • Activley seek information on new regulatory developments and inform relevant stakeholders across Cochlear of upcoming regulations in the EMEA region
  • Actively participate in selected industry, standard and regulatory association working groups such as IPQ, CEN/CENELEC, RAPS or Eucomed which are relevant according to Cochlear’s interests 

Product Registrations and Tenders

  • Ensure the EMEA regional entities are equipped with the relevant documentation for their tasks of product registration with local regulatory and reimbursement bodies
  • Ensure Customer Services are supported in requests relating to tenders with provision of documents and responses to queries in a timely manner to maximize the chances of winning the tender

 Documentation Approval and Product Life Cycle Management

  • Ensure participation in New Product Launch (NPL) and Roll-Out teams to represent the Regulatory Affairs function
  • Create policies, procedures and work instructions relevant for the Regulatory Affairs function in EMEA and contribute to relevant corporate procdures

Management of the EMEA Regulatory affairs team

  • Lead and coordinate 6 direct reports
  • Involve and liaise with any local Regulatory affairs representative based in different EMEA countries

About You

Requirements - Minimum:

  • Degree in Engineering, Science or Technology
  • At least 10 years industry experience
  • Demonstrated mastery of EU MDR, ISO13485 requirements
  • Demonstrated experience in achieving regulatory approvals (CE-mark) for medical devices
  • Demonstrated experience in people management and/or cross functional teams managment
  • Fluency in English language

Ideal:

  • Experience in a Regulatory leadership role in the Medical Device industry
  • Experience with drug-device combination products
  • Fluency in other European languages such as German, French, Italian, etc.
  • In addition to the above, the following also apply for the purposes of Article 15 of EU Regulation 2017/745:
    • a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline; and at least one year or professional experience in regulatory affairs or in quality management systems relating to medical devices (related to the EU requirements in the field)
    • or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices (related to the EU requirements in the field)

Developmental Opportunity

This is a fantastic opportunity to work across organisational boundaries across the whole Cochlear organisation. You will contribute to the development of global processes to meet new regulatory requirements and be the primary contact to the European Competent Authorities and Cochlear’s notified bodies. You will have the unique opportunity to travel up to 20% per month in accordance with the Cochlear EMEA travel policy.

Advertised: Romance Daylight Time
Anticpated Application Closing: Romance Daylight Time

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