Work ScheduleFirst Shift (Days)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.Location/Division Specific InformationThermo Fisher is seeking a Regulatory Affairs professional to join the area of molecular diagnostics to lead the Bio-Sciences Division Regulatory Affairs team in North America!This position is Remote.Discover Impactful Work:The Senior Manager will work in the Regulatory Affairs department and will establish and implement global regulatory strategies, lead FDA pre-submission package development and subsequent meetings, and author final product submissions (510(k)s, IVDR, etc.) and other global product submissions.A Day in the Life:
Responsible for providing guidance to assure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements.
Oversee ad/promo reviews to ensure regulatory compliance and support New Product Introduction (NPI) projects, ensuring they align with regulatory requirements and company policies.
Serve as a SME on various regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
Organize and conduct training sessions to enhance the team’s knowledge of working in a regulated environment.
Provide support and guidance across divisions. The delivery of regulatory guidance to project teams and external partners will be key activities toward assisting the Company in achieving its business goals.
Implement strategies for product submissions, facilitate and prepare U.S. regulatory Pre Submission or submission documents, and lead FDA pre submission and submission meetings.
Support and guide team members through submission and support global regulatory registration representatives for product registration activities.
Keys to Success:Education:
Bachelor degree in Biology, Chemistry, bio-engineering, or related science required.
Experience:
Minimum of 7-10 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices. This experience must include either BLA, 510(k), PMA, CE IVD submissions.
Well versed in the aspects of regulatory strategy creation, design control, cGMP/quality systems, and import/export requirements.
Experience as the RA representative on project core teams providing regulatory guidance and RA strategies.
Managerial competencies in leading impactful teams, demonstrating strong decision-making skills, and the ability to prioritize and deliver on multiple projects simultaneously.
Knowledge, Skills, Abilities:
High energy level; positive attitude; works well under stress, Strong communicator and leader. Hands-on, willing to take action, and able to implement effectively through their team.
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
Ability to provide solutions based on knowledge of regulation and experience.
Willingness to travel (10-15%).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.