Regional Senior Regulatory Affairs Specialist (Medical Device and Pharma)
PharmaRelations ApS
Linde Gas AB
Sweden - Stockholm
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About Linde Gas: Linde Gas is a global leader in providing industrial gases and engineering solutions. We are currently seeking a highly skilled and motivated Regional Senior Regulatory Affairs Specialist to join our dynamic team in Region Europe North.
Position Overview: As the Regional Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring patient safety and securing the certification of Medicinal Products and Medical Devices in Region Europe North. This is a full-time permanent position that involves leading and executing post-licensing activities, developing regulatory strategies, and ensuring compliance with laws, regulations, and standards.
Key Responsibilities:
· Act as PRRC for MD part b) and c) Art 15 MDR
· Keep Technical Documentation, including Declaration of Conformity, up to date
· Monitor regulatory requirements for MD and coordinate implementation on a regional level
· Design and develop new MD in project teams
· Coordinate Risk Management and Post Market Surveillance for Medical Devices
· Provide input and update QMS procedures for Medical Devices and Medicinal Products
· Assist in audits of MD as RA/QA and Notified Body audits
· Provide ad hoc regulatory support to colleagues, authorities, and customers
· Act as Linde EMEA Regulatory Competency Center contact manager for REN
· Coordinate and manage regulatory projects as part of the RCC
Qualifications and Experience:
· University degree in pharmacy, chemistry, or similar
· More than 3 years of work experience in Regulatory Affairs for MD and QA for Medicinal Products
· Solid knowledge of MDD/MDR, ISO 13485:2016, ISO 14971:2019, GMP, and GDP
· Experience in European pharma regulatory procedures such as MRP/DCPs/National submissions
· Excellent technical writing and review skills, fluent in English
Key Skills:
· Solid European pharma regulatory knowledge
· Experienced with eCTD-submission
· Scientific knowledge in the medical and pharmaceutical area
· Pedagogic training/explanation skills
· Strong integrity with a safety mindset
· Well-organized with the ability to coordinate complex projects
· Ability to discuss strategy and sensitive regulatory issues based on data
· Budget/cost sensitivity
For more questions about the role, please contact Moa Palm (Recruitment Manager) at [email protected].
We look forward to receiving your application!
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