14 days ago on careers.cochlear.com

Regulatory Affairs Manager EMEA

Cochlear AG

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Regulatory Affairs Manager EMEA

Regulatory Affairs Manager EMEA

Apply nowJob no:604846
Work type:Permanent
Categories:Western Europe, People Manager, Quality & Regulatory

Cochlear develops world-leading medical devices that help people hear. Around the world, more people chose a Cochlear-branded implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives. 

Within our "Europe, Middle East & Africa" (EMEA) Clinical, Technical, Research & Regulatory Department EMEA at the EMEA Headquarter in Basel, Switzerland we are seeking an  Regulatory Affairs Manager EMEA.

Position Overview / Purpose:

Lead the Regulatory Affairs function in the EMEA region to ensure compliance of Cochlear products with the relevant European Directives (AIMD, MDD, RTTE, etc), the European Medical Device Regulation (MDR) and the regulations in non European countries (Israel, Russia, Kingdom of Saudi Arabia, etc).
In a changing and complex regulatory environment the Regulatory Affairs Manager EMEA is accountable for developing and implementing the EMEA Regulatory Strategy and Plans. This role closely collaborates 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.
The role is the primary contact to the European Competent Authorities and Cochlear's Notified Bodies.


Accountability 1: 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 (Marketing and Clinical) and country organisations in order to achieve timely regulatory approval (CE-Mark) and registration of products in each of the EMEA markets
• Contribute to Post Market Surveillance Plans and ensure they are in line with regulatory requirements

Accountability 2: 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 including formal sign off of offers and invoices as per corporate signing authorities
• Review submissions for CE-Mark to ensure the submissions are compliant with EMEA requirements
• Organize pe-submission meetings and regular meetings on submission progress (bi-weekly) between the NBs and CLTD / CBAS
• Act as Cochlear's respresentative to the National Competent Authorities and Ministries of Health

Accountability 3: Regulatory Intelligence
• Activley seek information on new regulatory developments and inform relevant stakeholders in CLTD, CBAS and the EMEA entities 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
• Provide training to Cochlear staff in EMEA, CLTD and CBAS functions on new regulatroy and standard developments
• Participate in working groups responsible for implementing processes required to meet new regulatory requirements (new MDR)

Accountability 4: 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

Accountability 5: 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
• Review and approve product documentation, reports to ensure regulatory compliance
• Review Change Assessment Forms and sign them off according to the Change Control Procedure

Accountability 6: Vigilance Reporting and Field Safety Corrective Actions
• Ensure vigilance reporting to Competent Authorities is performed according to EMEA regulatory requirements, MEDDEV guidance and global policies
• Supervise team members resposnible for Vigilance Reporting
• Act as Safety Officer according to the German Medical Product Law and ensure the requested reports and reviews are available (trending and updating risk management file)
• Implement and supervise Field Safety Corrective Actions as required

Key Incumbent requirements: 


• Degree in Engineering, Science or Technology 

• At least 10 years industry experience 

• Demonstrated mastery of AIMD & MD directives, ISO13485 requirements 

• Demonstrated experience in achieving regulatory approvals (CE-mark) for medical devices

• Good communication, analytical and planning skills

• Ability to influence others

• Fluency in English language


• Experience in a Regulatory leadership role in the Medical Device industry

• Experience with drug-device combination products

• Fluency in German language

• Other European languages such as French, Italian would be a plus

Development Value of this role:

• Opportunity to work across organization boundaries across the whole organization of Cochlear

• Contribute to the development of global process to meet new regulatory requirements (MDR) 

Advertised:11 Oct 2016Romance Daylight Time
Applications close:

Back to search resultsApply now

Share this:|More
var addthis_config = {
"data_track_clickback": true ,
"data_ga_property": 'UA-3555366-20',
"data_ga_social": true