This is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, employees who find meaning in working with medical devices that improve patient outcomes, and a steadfast commitment to doing the right thing.
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States.
This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals for company products, providing strategic direction, oversight, and alignment with company processes, and ensuring company-wide compliance with all applicable United States federal and state regulatory requirements. This position will report to the Regulatory/Quality Director, based in the UK HQ.
Main Tasks/Accountabilities

• Lead regulatory strategy and submissions to the FDA and state regulatory authorities for new product approvals and supporting activities for existing ones.
• Provide regulatory guidance to the assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
• Review technical documentation, i.e. test reports, test protocols, etc., for completeness and compliance with regulatory standards. Review includes using scientific judgment to guide the teams in understanding how to close any gaps that exist.
• Timely compile materials for license renewals (including states), updates, and registrations.
• Review company marketing literature for compliance with applicable regulations.
• Maintain a thorough knowledge of current QSR and ISO requirements as they apply.
• May support some Quality Management Functions, as needed.

Qualifications & Skills:

• B.S. Degree in a Science or Engineering or equivalent business experience.
• At least 3 years experience working in the regulatory affairs department of a medical device company.
• Knowledge of global Class I, II and/or III medical device requirements is preferred.
• Demonstrated project management skills to plan, conduct, and implement system assessments.
• Experience and demonstrated success communicating with state and federal regulatory agencies.
• Prior experience handling FDA and Notified Body inspections is highly preferred.
• Professional certification(s) (e.g., RAPS, CQA, CQM and/or CQE) are desired but not required.
• Experience working with 510k submissions is desired but not required.
• Ability to interpret domestic and international regulations as they apply to company activities.
• Legally authorized to work in the United States.
• Licensed in California as Designated Representative in Charge for Wholesaler ("DRIC") preferred; qualifications to obtain DRIC license required. Qualifications can be found here: https://www.pharmacy.ca.gov/forms/exc_app_pkt.pdf

Work Conditions: This role is an in-office position at The Company's U.S. headquarters in Irvine, CA. Travel may be required to assist with inspections or meet with regulatory authorities as needed.