Regulatory Affairs Manager EMEA
Be the key person for R&A at a one of a kind company
Perfect fit for the R&A professional seeking ownership and impact
About Our Client
For our client OrbusNeich, located near to Amersfoort, we are exclusively recruiting a Regulatory Affairs Manager EMEA. This is high impact role is a key position in this specialized and innovative international company.
As Regulatory Affairs Manager EMEA you will report directly to the Vice President Regulatory Affairs & Quality Assurance. It is your responsibility to deliver all regulatory projects on time, with the committed scope and with an international mindset. You are responsible for registration of all OrbusNeich products in the EMEA countries where they aim to grow and distribute their products. This includes maintaining and updating existing product registrations, as well as create and submit new registrations for new products in existing or new countries. This role is a perfect fit for the R&A professional that seeks ownership and impact on an international scale.
- Be the key spokesperson in the company for R&A, both internally and externally
- Conduct regulatory activities with respective agencies (i.e. Ministry of Health, Chamber of Commerce, Competent Authority etc.) required to ship and receive product from and into the Netherlands.
- The correct execution, coordination and maintenance country registrations, company registrations, product registrations.
- Contact authorities if needed on the registration progress
- Maintain product registration status chart.
- Development, implementation and maintenance of a registration database.
- Provide local regulatory support as required by SZ RA.
- Assist with the reimbursement registrations process and support.
Other tasks to support the QA & RA team
- Assist in CAPA activities
- DHR control
- Assist in internal audits
- Coordination of DCR's at OrbusNeich BV
The Successful Applicant
- Bachelor's degree in Engineering, Life Science, or Similar
- 4+ years of work experience in R&A or Q&A
- Proven experience in registering new products in EMEA
- Professional command in both Dutch and English
- Experience in the Medical Device field is strongly preferred
- Accurate, a strong communicator and team player
What's on Offer
- Excellent primary and secondary benefits;
- Good growth and personal development opportunities.
- Working in a fast paced and dynamic medical device environment
- Have a positive impact on people's health and lives every day!