Why Join?

Our client is a leading manufacturer and distributor of medical devices with a focus on anesthesia and respiratory products. Every year they acquire, license, and launch several new innovative products to market. They sell to over 105 countries and have operations in 12 countries and in-house manufacturing overseas.

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 is an amazing opportunity to join an organization with outstanding leadership that prides itself on its high levels of quality, service, and value for its customers. There has never been a better time to join, and to be a part of their rapid growth as the U.S. subsidiary builds for the future!

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.