About this job
- Branche: Medical devices
- Area of expertise: Regulatory
- Location: Noord Brabant
What is required?
- Hours per week: 40
- Education level: Professional Bachelor
- Closing date: Friday, July 2, 2021
About this role
You will be a team member of the global regulatory organization and will be reporting to the Regulatory leader. The team you will be working in, is a high-performance, culturally diverse, and very dynamic team.
Support the running projects in worldwide submissions , drive under supervision of the RA core team member the prioritized countries by being the linking pin between core team and the RA leads in the countries. Therefore knowing and experience with rest of world submission or supported a US(510k)/EU(STED) submission is a must
The Regulatory Affairs Specialist works mostly with countries all over the world on the International registrations and support in special actions like CAPAs. This can be a person who is looking to get a better understanding how Regulatory works in the international market(outside of EU, USA, Canada and Japan).
You are responsible foro Work according the business applicable processes and as ambassador of the client values.
o Works with the RA Project Leads/RA Seniors to get the required information to get clearances for the products that are changed or released towards the markets.o Takes lead for RA CAPAs and support the RA team to close CAPAs
o Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations such as, but not limited to , CE marking and clinical evaluations.o Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions in the international markets.
o 1-4 years of experience in the medical device industryo Goal oriented, reliable, and extremely well organized with strong attention to detail.
o Demonstrates ability to work independently and work through projects with minimal supervision.o Affinity with medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations is a plus.
o Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide is a plus.
Join the Brunel CommunityWith a century of history and more than 450 innovative products and services, our client is ready to meet today's challenges within healthcare. They do this by creating solutions to provide better care to more people, at lower cost.
Their more than 12,000+ employees, working in countries worldwide, are dedicated to helping you create meaningful moments of care.
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