142906BR - Sr. Manager Regulatory Affairs
What will you do?
Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department.
Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
Document regulatory strategies for product submissions.
Facilitate and prepare U.S. regulatory Pre Submission documents for Next Generation Sequencing and/or PCR assays
Facilitate FDA pre submission meetings
Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
Support EU representatives in their creation of CE/IVD Technical Files
Support global regulatory registration representatives for product global registration activities
Perform regulatory assessment of new and changed products.
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
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, enhancement, and creation of internal policies and procedures.
Participate in business meetings with potential new external partners
How will you get here ?
Must have a minimum of 8 years of IVD Regulatory Affairs experience.
This experience must include either 510(k), PMA, PMA supplement submissions. Must be 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 active and successful regulatory guidance and RA strategies.
Experience in the balance and application of regulatory requirements
Direct and positive experience in communicating with Regulatory Authorities and co-development partners.
Regulatory review of promotional marketing materials, press releases, labeling, etc.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Capacity to communicate regulations to technical functions within the company
Knowledge, Skills, Abilities
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Thermo Fisher Scientific Inc.