Senior Specialist, Regulatory Affairs

United States, California, San Juan Capistrano

Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling, advertising, and product withdrawals and recalls. Provide pre‑market and post‑market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives. Supports applicable regulations including Local, State, Federal and/or international requirements.

We are proud to offer best‑in‑class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part‑time or full‑time position, some of the benefits offered may include:

• Medical/Prescription Drugs
• Dental
• Vision
• Flexible Spending Accounts (FSAs)
• Supplemental Health Plans
• 401(k) Plan - Company match dollar‑for‑dollar up to 5%
• Employee Stock Purchase Plan (ESPP)
• Supplemental Life Insurance
• Dependent Life Insurance
• Short‑ and Long‑Term Disability buy‑up
• Blueprint for Wellness
• Emotional Well‑Being Resources
• Educational Assistance
• Paid time off / Health Time
• Variable Compensation Plans
• Sales Incentive Plans

• Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling.
• Review and edit product submissions and other communications prepared by junior department members.
• Act as regulatory subject matter expert for junior department members.
• Provide pre‑market and post‑market regulatory strategy to ensure regulatory compliance and advance commercial objectives.
• Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage submissions such as US FDA Section 510(k) Notifications, Pre‑market Approval (PMA) Applications and Supplements, EU IVDR, Technical Documentation, ROW submissions and global product registrations.
• Independently communicate with regulatory agencies on pre‑market and post‑market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Provide back up to the Regulatory Affairs Director as needed.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health‑related programs and assist in solving safety and health problems.
  
  Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned. Provide technical and editorial direction to junior department members.

• BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required.
• Must have extensive knowledge of U.S., Canadian, European and other International In vitro diagnostic regulations and standards.
• At least three to five years of pre‑market regulatory experience in IVD industry. Clinical research experience desired, but not required.
• Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.
• Must…