Senior Regulatory Experts - Medical Devices

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

12d•$105,000 - $135,000•Hybrid

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Requirements

Employer requires a candidate to have at least a Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field and at least seven (7) years of progressively more responsible work experience developing and implementing global regulatory strategies for in vitro diagnostic medical devices in compliance with Regulation (EU) 2017/746 (IVDR) and European Directive 98/79/EC (IVDD), US FDA 21 CFR, UK MDR 2002, Canada Medical Devices Regulations (SOR /98-282).
Demonstrated knowledge of medical device or in-vitro diagnostics regulatory compliance while applying Quality Management Systems (21 CFR Part 820, ISO 13485:2016, MDSAP, IMDRF) including risk management, labeling, post market surveillance, stability, and design controls gained through at least five (5) years of work experience.
Demonstrated ability authoring complex regulatory technical documentation for submission to competent authorities and notified bodies following EU CE marking requirements under the Regulation 2017/746 (IVDR) and European country specific requirements gained through at least five (5) years of work experience.
Demonstrated ability utilizing software tools to design and develop, practical testing and implementation of Robotic Process Automation (RPA) solutions, including Phython, UiPath, and Microsoft Power automate to streamline regulatory processes gained through at least five (5) years of work experience.
Demonstrated ability conducting regulatory impact assessments and identifying regulatory risks early in the process for engineering changes to manufacturing processes and new product development initiatives, particularly for in vitro diagnostic (IVD) medical devices gained through at least two (2) years of work experience.

Responsibilities

Oversee and define roadmap for the global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices to global regulatory agencies and/or to commercial partners.
Develop and implement strategic frameworks for determining compliance requirements for in vitro diagnostic products in USA, EU, Canada, UK, Switzerland, countries outside of the EU including Latin American and Caribbean Region and Asia Pacific countries following country specific regulations.
Provide regulatory insights and action plans to cross-functional teams to ensure regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) FDA 21 CFR 820, CMDR SOR 98-292, IVDD 98/79/EC, ISO 13485:2016, IMDRF and other applicable International Medical Device Regulations. Contribute to Internal and external trainings of stakeholder.
Independently author, compile, and maintain technical files and other regulatory documentation to ensure timely registrations and renewals in compliance with In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by strategically implementing digital solutions such as RPA tools data, analytic tools, and ERP systems. Review technical dossiers compiled by other SMEs.
Review and approve quality management system documentation related to post market surveillance, risk management, stability etc. required for conformity assessment by notified body. Respond to the deficiency letters issued by notified bodies and regulatory agencies.
Respond to regulatory inquiries from internal and external customers and actively participate in inspections by authorities and notified bodies implementing corrective and preventive actions (CAPA) as needed. Keeping up to date regulatory standard operating procedures for audit readiness.
Implement defined strategic frameworks for assessing the regulatory implications of engineering changes to manufacturing processes and final products, facilitating informed decision making that aligns with both compliance requirements and business objectives.
Monitor and analyze global regulatory developments for in vitro diagnostic medical devices, lead regulatory surveillance and advocacy activities in accordance with regulatory intelligence procedures. Coordinate and facilitate training sessions for internal and external stakeholders as needed.
Manage regulatory review process for labeling materials including labels, instructions for use, package inserts, advertising/promotions materials, CoAs and websites, ensuring compliance with applicable global regulations.
Provide regulatory assessment for new product development initiatives including identifying regulatory risks, tracking timelines and submission deliverables to ensure alignment with regulatory requirements and market needs.
Manage recall or notification actions as needed and ensure effective execution of regulatory vigilance reporting to global regulatory authorities.
Mentor junior team members to support their onboarding and development etc.