Are you passionate about making a difference? Do you want to be a part of a company known to be a fast paced global leader in serving science? Do you have a Regulatory Affairs background from a similar role with Medical Devices then you may be the one we are looking for.
Our customers are world leading pharma and diagnostics companies who have chosen us as their business partner, and we take great pride in being there for our customers, ensuring total customer satisfaction. At the Roskilde site we produce a variety of consumables (branded NUNC) for the medical and biotech industry.
We are looking for a new colleague with real integrity and can-do-attitude to join our dedicated team of Quality and Regulatory Affairs professionals. As Regulatory Affairs Specialist you will be responsible for providing Regulatory Affairs guidance, support and continued compliance with internal procedures, and applicable regulatory and international standards and legislation.
Reporting to the Quality Manager you will provide RA guidance, maintain and update medical device regulatory filing including product registrations, FDA 510k’s, and Technical Files. The position will be vigilant of implementing updatedstandards and regulations and their impact on product regulatory status. In addition, the RA specialist will also handle post-market Surveillance.
- Prepare, submit and manage regulatory filings required for product market approvals as necessary
- Prepare, submit, manage and maintain Technical Files in compliance with the requirements of the MDD/IVDD and the Quality Management System
- Function as a RA subject matter expert on new product introduction and engineering design control teams
- Assist the organization, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements and as appropriate
- Lead post market surveillance activity including assembling necessary evidence and prepare Summary reports as appropriate
- Lead potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports
- Provide guidance regarding regulatory and compendia performance test requirements such as biocompatibility and sterility
Experience and qualifications needed to succeed
- Relevant degree in Science; Engineering, Pharmacy, Biology, Biochemistry or similar work experience
- Min 3 years RA experience, preferably form Medical Device (IVD, IVF) with working knowledge of device classification processes (domestic and international such as US, Canada, Australia, China, Japan)
- Working knowledge of ISO 13485 and regulatory requirements for medical devices (including MDD 93/42/EEC, IVDD 98/79/EC, FDA CFR 21 part 820, CMDR)
- Working knowledge of EN ISO 14971:2012 and experience in utilizing of Risk Management techniques (health hazard evaluation, fault tree analysis, dFMEA, pFMEA etc) for medical devices is required
- Experienced with post market surveillance activities and familiar with test methods, sampling plans and standard for the design, verification and validation of medical devise products (including sterilization, biocompatibility and packaging validation) is a plus.
- Strong critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture
- Organized, structured and decisive with the ability and willingness to work in ambiguous situations
- Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner
- Committed and self-driven with a positive mindset, flexibility and persistence
What we offer
- A career in an international company with global impact
- Be part of exciting project to improve human condition
- Development through continuous learning
- Cooperation with driven colleagues across business areas
- Opportunity to work with the best teams in the industry, ranging from international top level scientist to cutting edge process- and production teams and highly creative business- and marketing teams
- Application deadline is July 2nd 2017 with 1st round of interviews planned for week 29
If you have questions about Thermo Fisher and/or the position please contact Heidi Lund-Nielsen (Sr. Recruiter Talent Acquisitions Nordic) via email Heidi.email@example.com
We look forward to receiving your application including a motivational letter and a CV