Regulatory Manager

Description

We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This role is key in driving strategy for both new product development and engineering lifecycle management.

Key Responsibilities:

- Development and execution of regulatory strategies for New Product Development and sustaining engineering projects

- Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified Bodies.

- Address submission deficiencies

- Manage full project/ product lifecycle as main representative on cross- functional product development teams (R&D, Engineering, Quality, Manufacturing, Clinical and Marketing) to ensure regulatory requirements are integrated into product development and documentation

- Communicate impact to internal stakeholders

- Support Audits and inspections

Skills and Qualifications:

Demonstrated leadership experience in managing regulatory teams or projects

- e‑STAR experience = ability to effectively prepare and submit FDA-compliant device filings

- Proven track record of successful submissions to, and experience interacting with, US FDA and EU Notified Bodies.

- Experience supporting both new product development and sustaining activities.

- Strong understanding of global medical device regulations (e.g., FDA CFR, EU MDR).

Skills

Regulatory, new product development, quality, 510(k), Project management, engineering, MDR, EU MDR, US FDA, regulatory submission, Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs, CMC, manufacturing controls, RAC certification, e star, e‑STAR, electronic resource template and resource, PMA, Post market analysis, design control, design, analysis, root cause analysis, quality assurance, PMS, post market surveillance, FDA, CFR, CFRA

Top Skills Details

Regulatory,new product development,quality,510(k)

Additional Skills & Qualifications

Advanced Engineering Degree a PLUS

CMC (Chemistry, Manufacturing, and Controls) experience is a plus but not required

RAC certification or equivalent is a plus.

Job Type & Location

This is a Permanent position based out of Lake Forest, CA.

The pay range for this position is $150000.00 - $200000.00/yr.

100% employer paid benefits medical dental vision employee stock program

This is a fully onsite position in Lake Forest,CA.

This position is anticipated to close on Dec 19, 2025.

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.