EMEA Regulatory Affairs Coordinator
Job no: 612396
Work type: Fixed Term Contract (Cochlear payrolled)
Categories: Quality & Regulatory, Western Europe, Individual Contributor
Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Cochlear's mission is to help people Hear and Be Heard.Our EMEA Regulatory Affairs department is currently looking for a Regulatory Affairs Coordinator for a 12 Month term contract based in our location in Basel.
The position of the Regulatory Affairs Coordinator is to support the EU Medical Device Regulation (MDR) Project team. They will coordinate regulatory activities to transition Cochlear’s medical device certifications across the Europe, Middle East and Africa (EMEA) region.
- Project coordination in transition products from existing CE Mark certification to the new Medical Device Regulation (MDR) certification
- Track and report status of product registrations, changes and other country submission across the region
- Track and report status of the legal Manufacturer’s transition to MDR CE marking of the product portfolio. The availability of MDR compliant medical devices to the region and any deviations to plans is a key input to the EU MDR Transition project
- Escalation (for example to the EMEA regulatory team and EU MDR Transition Manager) of issues and delays associated with either CE Marking submissions and or country registration activities
- Participate in regular project meetings with the EU MDR Transition Team
- Provide regular reports and updates to the Regulatory Subject Matter Experts
- Responsible for the entry and maintenance of Regulatory Information in Databases and Trackers. (MDR Product release trackers, Product Information Database, Registration and certificate trackers, Cochlear Regulatory Affairs Management System (RAMS), Supporting updates to registration databases for the United Kingdom and Germany, European Database for Medical Devices (EUDAMED) Economic Operator Actor Module and others)
- Supporting regulatory affairs submissions through compiling and distributing technical documentation
- Supporting and arranging meetings, minutes and agendas for the EMEA Regulatory Affairs Team
- Maintenance of team websites and intranet
- Compiling monthly reports
- Administration and project coordination experience
- Organizational skills
- Attention to detail
- Self-sufficient and can take initiative when something isn’t working well or could be improved
- Demonstrated experience of meeting deadlines
- Fluent English
- Strong computer literacy with Excel expertise
- Previous experience of working within a regulated environment
- Interested in developing a career in regulatory affairs
- Ability to write and improve standard operating procedures and work instructions
- Knowledge of other European languages
- Some flexibility to accommodate working with colleagues in different time zones around the world
Working for Cochlear:
For 40 years, Cochlear has been creating reliable products that continue to keep people connected to the world and to each other. We help people of all ages to hear in more than 180 countries around the world. Our technology connects people to life's possibilities and to the people who matter most. We have over 4000 employees globally dedicated to improving people's lives. To date, we have Invested over $2bil to date in research and development.
Cochlear can offer:
The Work - A high impact job supporting world leading technology
The Organisation – The global leader in implantable medical device hearing technology
The Opportunity – To make a difference to the quality of people’s lives
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Visit www.cochlearcareers.com for more information.
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 Standard Time
Anticpated Application Closing: Romance Standard Time
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