A seasoned regulatory affairs leader and subject matter expert able to ensure that departmental objectives are implemented in line with the overall site, department, and corporate goals and objectives. Dedicated to ensuring continual compliance to all applicable regulations. Manage assigned regulatory tasks related to health authority notifications / submissions / registrations in regard to new products, changes to products or sale of products in new territories. Ensure site regulatory strategy aligns with overall corporate regulatory strategy, goals and objectives. Carry out regulatory review of documents and changes. Carry out impact assessments where required. Review customer complaints for incidents requiring vigilance reporting or regulatory involvement. as assigned through the Quality System as appropriate. Assemble and maintain technical files, device master records and other regulatory documentation to ensure current, and changes recorded. Maintain library/database of standards and regulation. Review of updated standards and regulations, carry out documented review, ensuring any necessary updates are made and disseminating information throughout the site. Manage regulatory review for new product introductions, CAPA investigations, printed materials, validations and general projects. Support preparation of and participate in any customer audits which require regulatory input. Support preparation for and participate in audits by regulatory bodies. Carry out regulatory gap analysis and audits related to changing or new regulations. Respond to customer (internal & external) regulatory requests or enquiries. Support any recall or notification actions & carry out regulatory vigilance reporting as required. Act as liaison between site and notified body or other regulatory authorities.
Who You Are:
BS in Biology, Biochemistry, or similar relevant science discipline.
3+ years regulatory affairs experience.
Working knowledge of FDA IVD regulations.
Working knowledge of MDD regulations.
Working knowledge of IVDD/IVDR.
Experience with global product registrations.
1+ year of previous supervisory / lead / management experience.
Working knowledge of LATAM, APAC and EMEA regulations.
Experience dealing specifically with Class 1 invitro diagnostics.
Regulatory experience with invitro diagnostics.
Employer will assist with relocation costs.
Internal Number: 197342
About Millipore Sigma
A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.