Senior Regulatory Affairs Specialist
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Roskilde
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .
Overview
How will you make an impact?
Exciting new opportunity for a Regulatory Affairs professional to join our small but dedicated Regulatory Affairs team based at our production site in Roskilde, Denmark.
In this role you will provide regulatory affairs support, maintain and update medical device regulatory filing including product registrations, and technical files
The position will be vigilant of implementing updated standards and regulations and their impact on product regulatory status. In addition, you will also support the Regulatory Affairs Manager in driving the Post Market Surveillance activities and will act as a regulatory consultant for other functions to ensure regulatory compliance across all products and processes.
What will you do?
• Ensure availability of up-to-date Design History Files for regulated products
• Prepare, submit and manage regulatory filings required for product market approvals as necessary
• Function as a RA subject matter expert on new product introduction and engineering design control teams
• Support post market surveillance activity including assembling necessary evidence and prepare Summary reports as appropriate
• Support potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports
• Provide regulatory input to QA in Deviations, CAPAs and complaints
• Provide guidance regarding regulatory and compendia performance test requirements such as biocompatibility and sterility
How will you get here?
Education
• B.Sc. degree in Biology, Chemistry, Life-Science, bioengineering or equivalent
Experience
• +5 years RA experience from Medical Device with working knowledge of device classification processes (domestic and international such as US, Canada, Australia, China, Japan)
• Experience with MDR / IVDR implementation for Class I / II devices
• Experience with post market surveillance activities and familiar with test methods, sampling plans and standard for the design, verification and validation of medical device products (including sterilization, biocompatibility and packaging validation) is a plus
Knowledge, Skills, Abilities
• 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 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
At Thermo Fisher Scientific, each one of our 70,000 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!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Overview
How will you make an impact?
Exciting new opportunity for a Regulatory Affairs professional to join our small but dedicated Regulatory Affairs team based at our production site in Roskilde, Denmark.
In this role you will provide regulatory affairs support, maintain and update medical device regulatory filing including product registrations, and technical files
The position will be vigilant of implementing updated standards and regulations and their impact on product regulatory status. In addition, you will also support the Regulatory Affairs Manager in driving the Post Market Surveillance activities and will act as a regulatory consultant for other functions to ensure regulatory compliance across all products and processes.
What will you do?
• Ensure availability of up-to-date Design History Files for regulated products
• Prepare, submit and manage regulatory filings required for product market approvals as necessary
• Function as a RA subject matter expert on new product introduction and engineering design control teams
• Support post market surveillance activity including assembling necessary evidence and prepare Summary reports as appropriate
• Support potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports
• Provide regulatory input to QA in Deviations, CAPAs and complaints
• Provide guidance regarding regulatory and compendia performance test requirements such as biocompatibility and sterility
How will you get here?
Education
• B.Sc. degree in Biology, Chemistry, Life-Science, bioengineering or equivalent
Experience
• +5 years RA experience from Medical Device with working knowledge of device classification processes (domestic and international such as US, Canada, Australia, China, Japan)
• Experience with MDR / IVDR implementation for Class I / II devices
• Experience with post market surveillance activities and familiar with test methods, sampling plans and standard for the design, verification and validation of medical device products (including sterilization, biocompatibility and packaging validation) is a plus
Knowledge, Skills, Abilities
• 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 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
At Thermo Fisher Scientific, each one of our 70,000 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!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 1.10.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Roskilde
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