Manager, Regulatory Affairs

at  Thermo Fisher Scientific

JOB DESCRIPTION

DUTIES: • Lead a team to contribute in establishing strategy for worldwide product approval submission activities, directly responsible for submission activities and for ensuring regulatory compliance.

• Implement policies, procedures, practices and strategies for Regulatory Affairs.
• Collaborate with International RA, R&D, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.
• Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products’ registration.
• Participate on product development teams, providing regulatory strategies, timelines, and direction.
• Review and approve technical documentation.
• Drive product change assessments and define regulatory impact of product changes in global markets.
• Review and approve labeling, training, promotional, and advertising material.
• Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Ensure compliance with Thermo Fisher Scientific, U.S. FDA, EU MDR/IVDR, Korea MFDS, China NMPA and other international medical requirements.
• Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, HHE, issue assessments).
• Facilitate and prepare U.S. regulatory Pre Submission documents and pre submission meetings.
• Regulatory expert support IVDR teams, implement regulatory strategies for IVDR activities; provide regulatory leadership; collaborate with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
• Prepare document vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, PM, De Novo, and technical files for CE marking.
• Lead a team to support global regulatory registration activities.
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings.
• Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
• Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.
• Participate in business meetings with external partners as needed.
• Participate in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.

REQUIREMENTS: MINIMUM Education Requirement: Master’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study. MINIMUM Experience Requirement: 5 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Affairs Specialist, or a related occupation.
Alternative Education and Experience Requirement: Bachelor’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Affairs Specialist, or a related occupation.

Required knowledge or experience with:

• Submissions to the FDA such as 510(k), De Novo, PMA, or PMA supplement submissions;
• Regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements;
• Reviewing design specifications and other technical documents;
• Acting as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies;
• Communicating with Regulatory Authorities and Distributors;
• Regulatory review and assessment of promotional marketing materials, press releases, labeling;
• Mentoring junior colleagues;
• Experience in EU MDD/IVDD or MDR/IVDR;
• MS applications (Excel, Word, Outlook); and
• FDA QSR 21 CFR 820, U.S. medical device and in vitro diagnostic regulatory requirements, IVD Directive requirements, and ISO standards.

Salary: $271606 to $297400 per year

• Implement policies, procedures, practices and strategies for Regulatory Affairs.
• Collaborate with International RA, R&D, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.
• Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products’ registration.
• Participate on product development teams, providing regulatory strategies, timelines, and direction.
• Review and approve technical documentation.
• Drive product change assessments and define regulatory impact of product changes in global markets.
• Review and approve labeling, training, promotional, and advertising material.
• Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Ensure compliance with Thermo Fisher Scientific, U.S. FDA, EU MDR/IVDR, Korea MFDS, China NMPA and other international medical requirements.
• Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, HHE, issue assessments).
• Facilitate and prepare U.S. regulatory Pre Submission documents and pre submission meetings.
• Regulatory expert support IVDR teams, implement regulatory strategies for IVDR activities; provide regulatory leadership; collaborate with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
• Prepare document vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, PM, De Novo, and technical files for CE marking.
• Lead a team to support global regulatory registration activities.
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings.
• Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
• Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.
• Participate in business meetings with external partners as needed.
• Participate in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information