Director Regulatory Affairs, Emea
vor 19 Stunden
Director Regulatory Affairs, EMEA
**Job no**: 615328
**Work type**: Permanent
**Location**: Basel
**Categories**: Quality & Regulatory, Western Europe, People Manager
**About Us**
Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Our mission is to help people hear and be heard.
**The Opportunity**
Lead the Regulatory Affairs function in the EMEA region as the Director Regulatory Affairs, EMEA. This is a great opportunity to develop and implement the EMEA Regulatory Strategy and plans as you ensure compliance of Cochlear products with the European Medical Device Regulation (MDR). You will collaborate closely with the Global Regulatory functions as well as the General and Functional Managers in the EMEA region to develop the plan for market access and ensure regulatory compliance in the EMEA region. Position based in Basel ideally or in any European hub.
Your responsibilities will include
- Regulatory Strategy and Plans
- Contribute to the development of corporate regulatory strategies in collaboration with corporate functions (CLTDand CBAS) 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
- Actively 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 procedures
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.
- 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.
**Cochlear Summary**
Cochlear’s mission is to help more people to hear. Around the world, more people chose a Cochlear
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