A large Biopharmaceutical company based in San Diego, California is looking for a Manager of Regulatory Affairs to join their team

Job Description:

The qualified candidate will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for international and domestic product registrations, permits and licenses.

 Assists in the evaluation of change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc.

Participates on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, corrective/preventive action, audits, training, recalls/field corrective actions, MDR/MDV, etc.).

Tasks and Responsibilities:

- Participates on product project teams with responsibility for determination of regulatory submission needs, proposal of regulatory strategy, and preparation of documentation for international and domestic new product registrations permits and licenses

- Interfaces with state, federal, international regulatory agencies as well as international distributors regarding registrations and licenses.

- Participates on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, corrective/preventive action, audits, recalls/field corrective actions, MDR/MDV, etc.)

- Ensures compliance to all relevant regulatory requirements and standards.

- Ensures product technical files, documentation and relevant clinical/scientific literature are maintained and periodically updated as required.

- Generates/revises documentation and data necessary for department operations (e.g. SOPs, forms, tables, records, reports, meeting summaries, etc.).

- Evaluate change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc.

- Additional projects as required

- Travel to company affiliates, industry conferences/meetings or external training events may occur as required.

Qualifications:

- Minimum bachelor’s degree (BS/BA) in any biological science (or equivalent combination education and/or work experience) with 3+ years regulatory experience in a medical device or IVD manufacturing environment.

- Strong knowledge of quality systems in a manufacturing environment; working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of IVDs and medical devices.

-Preference given to those with IVD experience especially in the cardiovascular or home-testing markets, and/or to those with demonstrated CLIA waiver experience.

-Ability to work cohesively with multi-disciplinary scientific working groups and regulatory agencies.