Global Regulatory Affairs Manager

OssDsign is expanding and looking for a Regulatory Affairs Manager to join their business in Uppsala. This is an opportunity to work with exciting products and dedicated people in an international environment!

Responsibilities

• Maintains and communicates current knowledge of the developments and changes to applicable laws, regulations and industry standards
• Develop and implement regulatory strategies for new and modified products and regulatory processes
• Representing Regulatory affairs as core team member in product development, product improvement and production improvement projects
• Manage submissions to obtain and maintain global regulatory approvals of products
• Communication with competent authorities and/or notified body regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
• Procurement and management of external regulatory consulting and contracting resources to assist, as agreed with senior management.
• Review and approve product and manufacturing changes for compliance with applicable regulations.
• Review and approve device labelling and promotional materials to ensure compliance with applicable regulations.
• Provide internal expertise and guidance in interpreting regulations and agency guidelines
• Represent Regulatory Affairs in internal and external audits

Qualifications

• Minimum Master of Science in Engineering/Chemistry/Biology/Medicine or similar
• Desireable to have at least 8-10 years experience within the Medical Device industry .
• At least 5 years experience within Medical Device Regulatory Affairs. Knoweledge of, and experience in, the Orthopaedics sector an advantage
• Background from product development and/or production based environment.
• Deep knowledge on medical device regulations in EU, US and desireable also Japan
• Experience of regulatory requirements for implantable class III medical devices and implantable custom made devices
• Experience of compilation and submission of technical documentation for implantable class III medical devices
• Experience of both compilation of documentation for both the 510(k) and PMA/IDE FDA pathways
• Ability to interpret the regulations in different countries.
• High degree of integrity and responsibility and ability to work independently of others.
• Ability to work as part of a team and to work with people from across the whole company.
• Able to speak and write fluently in English and Swedish.
• Ability to communicate effectively with global regulatory authorities
• Ability to clearly communicate options, opportunities and risks to internal stakeholders.
• Robust and persuasive, with the ability to effectively resolve functional disagreements with a collegiate, non-confrontational style
• Organized, structured and accurate way of working.
• Strong analytical skills.

Apply today!

To apply, please send your CV and a cover letter asap to Daniel Kremer at; daniel.kremer@moveup.se

If you have questions regarding this open position, please contact Daniel at +46 (0)733 87 27 24.

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