Regional Senior Regulatory Affairs Specialist (Medical Device and Pharma)

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!