Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Onsite 5 days a week. Hard 5pm Stop- Favor work life balance.

Job Description

We are seeking a dedicated and experienced Regulatory Affairs Manager to lead our regulatory submissions, registrations, and licensing documentation efforts. This role is essential for ensuring compliance with regulatory standards and maintaining the quality management system.

Responsibilities

• Oversee and coordinate all positions related to Regulatory Affairs.
• Ensure processes for regulatory compliance are established, implemented, maintained, and continuously improved.
• Evaluate products and concepts for compliance with regulatory requirements.
• Monitor compliance with Regulatory Standards and the Quality Management System (QMS).
• Serve as the primary contact for State, Federal, and International Agencies, and lead regulatory and notified body/ISO Registrar audits.
• Communicate with Notified Bodies, ISO Registrars, and foreign distributors about product and quality system changes.
• Report applicable regulatory requirements to top management and provide regulatory guidance throughout the organization.
• Plan, prepare, and conduct Management Review meetings.
• Plan and implement QMS and applicable regulatory training.
• Manage and improve internal audit systems, customer complaints/feedback, regulatory adverse event reporting, product recalls, and clinical evaluations.
• Support OEM customer audits and clarify regulatory policy.
• Supervise employees and make decisions regarding hiring, discipline, and performance evaluations.
• Communicate effectively with coworkers at all levels.
• Work independently to perform daily operating tasks.

Essential Skills

• 2 years of regulatory affairs experience with a Bachelor's degree in Biology or 6 years with a high school diploma.
• Experience in regulatory submission, regulatory affairs, and regulatory compliance.
• Experience with medical devices, implants, pharmaceuticals, and quality assurance.
• Knowledge of FDA QSRs and current 21 CFR and ISO standards.
• Ability to assess performance, guide subordinates, and analyze training needs.
• Strong written and verbal communication skills in English.
• Ability to maintain accuracy and consistency in a fast-paced environment.

Additional Skills & Qualifications

• Knowledge of medical device manufacturing or related fields.
• Ability to read, analyze, and interpret technical documents and regulations.
• Experience in writing reports, business correspondence, and procedure manuals.
• Flexibility in changing daily workload priorities.
• Understanding of biocompatibility, sterilization, packaging concepts, and silicone properties.
• Ability to apply risk management concepts and standards.
• Manual dexterity for performing detailed work.

Work Environment

The company consists of 72 employees, all working onsite in one office building in Ventura. The QA team comprises 5-6 people, and the RA team includes this manager and an admin. The work environment is very casual, with most employees wearing jeans and a polo or nicer top. The company values work/life balance, ensuring everyone finishes work by 5pm.

This is a Permanent position based out of Ventura, CA.

The pay range for this position is $98000.00 - $150000.00/yr.

- 401k, medical and dental

This is a fully onsite position in Ventura,CA.

This position is anticipated to close on Mar 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $98,000 - $150,000