Johnson and Johnson are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopaedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We build smart, people-centred healthcare to help the patients we serve to recover faster and live longer and more vibrantly.
The function of a Specialist Regulatory Affairs EMEA is to provide support to get registrations and market authorizations in countries of the EMEA.
Regulatory Affairs Specialist enables medicinal products and medical devices that are developed, approved by Competent Authorities /Notified Bodies, manufactured or distributed to meet required legislation and assure Regulatory Compliance throughout their life cycle.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
You will support the Manager Regulatory affairs for these key duties and responsibilities:
- Working closely with the Global RA Team and the regional EMEA RA Manager on Notified Body submissions for new products and significant changes in the region.
- Provide RA support to achieve local registrations and market authorizations in the EMEA region and submit to national authorities and also supporting other regional RA departments which rely on the European registrations
- You will review (in view of compliance with regulatory requirements) technical files, review and approve text drafts and artworks of labels packaging and instructions for use for assigned products
- Global Regulatory impact assessments for all changes at the manufacturing sites and you will ensure that the submission of relevant changes to the Notified Body.
- Supporting the Regulatory Affairs manager with regards to Notified Body audits at manufacturing sites.
- Supporting the Regulator Affairs manager for Regulatory distribution release for medical devices.
- A university degree in medical device engineering, life sciences or a long-term healthcare industry background is required.
- You should have previous medical device regulatory experience especially regulations for labelling and change requirements; alternatively, regulatory experience with medical products is acceptable
- Knowledge about Medical Device Regulation (MDR) regulations is an advantage.
- Your experience with Notified Bodies in new product registrations is of advantage along with experience with ophthalmological medical devices.
- Language requirement: Fluent English and German would be advantageous
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
AMO Germany GmbH (7137)