Regulatory Affairs Associate, EMEA
Job no: 608823
Work type: Permanent
Categories: Western Europe, Individual Contributor, Quality & Regulatory
Unique opportunity to join our dynamic regulatory team, for a rewarding and challenging career in a multinational work environment. This role will have a significant contribution in ensuring Cochlear’s readiness and compliance to the European Medical Device Regulation. This is not just a Regulatory Affairs (RA) project, but involves all areas of the business! You will already have worked within this field of expertise but evidence a true understanding of the importance of RA best practice. The current RA Team will provide great training and support. You will be given the freedom to make decisions in a very collaborative environment. This position requires a multi-disciplinary skills-set and has very strong global career potential. The RA Associate will play a critical role in regulatory submissions, license renewals and registrations within the Europe, Middle East and Africa (EMEA) region. You will work closely with employees from all functional areas to ensure clear, concise and accurate documentation is submitted to regional partners and regulators.
- Higher education (technical or science), or appropriate work experience.
- Training/ further education in regulatory affairs (if not already in first education).
- Prefer experience in the medical devices industry.
- Experience with medical devices (class IIb or above).
- Exposure within an international matrix organisation.
- Working knowledge of Medical Device Regulation (MDR), Medical Device Directive (MDD) and/or Active Implantable Medical Device Directive (AIMD).
- Demonstrated ability to identify and implement process improvements.
- Good analytical and planning skills.
- Evidence Cross-cultural communication.
- Experience with MS Office (especially MS Excel for example creation of graphs and use of formulas).
- Languages: English (fluent speaking & writing).
- Worked in regulatory role in corporate environment (HQ, central functions).
- Experience with active implantable medical devices (class III).
- Proven track record of management, compilation, submission and maintenance of regulatory filings.
- Working knowledge of EN ISO 13485, MDR, AIMD and MDD.
- Languages: English, German (fluent speaking & writing)/ any other European language is a plus.
Duties and Responsibilities:
Regulatory Strategy and Planning
- Support the regulatory strategy and business plans by ensuring regulatory submissions are submitted within agreed timelines and according to local regulatory requirements.
- Be able to link and escalate the impact of local Regulatory activities with marketing plans.
- Actively cultivate a good relationship with regulatory authority personnel, assist in organising meetings, and communicate information about authorities to relevant parties in Cochlear.
Compilation, submission, approval and maintenance of Regulatory Files
- Assemble and compile files for submissions, product license renewals and registrations according to regulatory requirements.
- Plan and prepare submission packages for regulatory authorities according to submission timelines.
Handle, review and submit responses to submission questions/issues.
- Store and archive regulatory documentation according to company procedures. Provide information, certificates and additional documents as required.
- Maintain a system to monitor, track and communicate regulatory status.
Prepares or assists in preparation of renewals, changes, and routine reports.
- Participates in the review of departmental SOPs.
- Provides support for regional subsidiaries, offices and distributors in working with local regulatory authorities.
Provide cross-functional regulatory support
- Provide support to ensure compliance of clinical studies, advertising material, labelling and publicly disseminated information with relevant laws & regulations.
- Provide regulatory support in the assessment of changes and new product developments.
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing 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. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age.
In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.
Advertised: Romance Daylight Time
Back to search results Apply now