Director of Regulatory Affairs

JOB TITLE: Director of Regulatory Affairs

DEPARTMENT: Regulatory

REPORTS TO: Chief Compliance Officer

Salary: $160,000 - $180,000

JOB SUMMARY

The primary responsibility of the Director of Regulatory Affairs is ensuring full organizational compliance with all relevant regulations and industry standards (FDA and EU). This role will develop and implement comprehensive regulatory strategies, oversee regulatory submissions and approvals, and manage a small team. The Director of Regulatory Affairs stays abreast of evolving regulations, conducts continuous risk assessments, and collaborates with internal departments to maintain compliance. This position is based in-office Monday through Friday, 8am-5pm in Laguna Hills, CA.

ESSENTIAL DUTIES AND RESPONSIBILITIES

·      Supports and prepares documentation for regulatory submissions and registrations, maintaining current knowledge of FDA and international (EU) regulations.

·      Maintains and supports compliance activities associated with Quality Management System (QMS).

·      Authors and maintains regulatory design dossiers, technical files, device master records, design history files, essential requirements checklists, standard lists, and other regulatory files.

·      Supports new product launches, risk management activities, regulatory plans, product V&V, process validation, and design transfer into manufacturing. 

·      Reviews changes to existing products, SOP’s, DOP’s, test methods, process/design changes, labeling, and field issues to define the requirements for regulatory submissions and notifications.

·      Conducts regulatory reviews of customer complaints and reportability (MDR & MDV).

·      Communicates with FDA and notified body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.

·      Reviews marketing and advertising materials for appropriateness and compliance with applicable laws.

·      Represents Regulatory Affairs on Engineering and R&D product development project teams to ensure all requirements are met throughout development.

·      Recommends modifications of existing quality or production standards to achieve optimum quality and compliance.

·      Completes projects in a manner consistent with corporate objectives.

·      Performs additional duties as required.

JOB QUALIFICATION REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The ideal candidate will be a competent problem-solver, with high-level interpersonal and communication skills.

·      Bachelor's degree (B.S.) in health sciences, or a related discipline required from an accredited four-year College or University. Master’s degree from an accredited University preferred.

·      4-6 years’ experience in regulatory and medical device industry.

·      Progressive managerial experience in an area relevant to this role and its primary duties.

·      Current knowledge of FDA Guidelines, Medical Device Directives, and standards applicable to company products.

·      Self-starter with strong analytical, organizational, and planning capabilities.

·      Ability to adjust to rapidly shifting priorities and excel under pressure.

·      High proficiency in Microsoft Office Suite.