Sr. Manager Regulatory Affairs

Job Description:

142906BR - Sr. Manager Regulatory Affairs

San Diego

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

Education

• A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.

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

• EVAMOPS2020 *GTSDouble