Do you want to be a part of a company known to be a fast paced global leader in serving science? Are you passionate about making a difference, and are you looking for a role where you can assume the responsibility for directing and developing Regulatory Affairs, whilst applying your RA expertise within 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 (Nunc products) for the medical and biotech industry.
We are seeking a Regulatory Affairs Manager with real integrity and can-do-attitude to join our dedicated team of Quality and Regulatory professionals in Roskilde. As Regulatory Affairs Manager you will be responsible for the development as well as setting the direction within the Regulatory Affairs. You will provide RA guidance and support to ensure continued accuracy and compliance with international standards, internal procedures, applicable regulatory and legislation. In addition the Regulatory Affairs Manager will be key in the development of the Regulatory strategy for Roskilde and Europe.
To be successful in this role you will have to show a strong understanding of Regulatory Affairs, and have experience within the Medical Devices sector, preferably with a focus across new regulations in the EU.
Reporting to the Quality Senior Manager this newly created and key role will provide RA guidance in projects (e.g. development), maintain and update medical device regulatory filing (MDR, IVDR) including product registrations, FDA 510k`s, and Technical Files. In addition you will also be responsible for post-market Surveillance process.
- Prepare, submit and manage regulatory filings required for product market approvals and registrations in different markets 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
- Significant experience working with Regulatory Affairs from 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
We will review applications on an ongoing basis in order to start the interview and hiring process as soon as possible, so please do not hesitate in making your application.
If you have questions about Thermo Fisher and/or the position please contact Heidi Lund-Nielsen, Senior Recruiter via email Heidi.email@example.com
We look forward to receiving your application including a motivational letter and a CV in English
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
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