Regulatory Affairs Specialist

Job Description

Job Description

JOB POSTING: Regulatory Affairs Specialist

Location: Torrance, CA (Onsite)

Industry: Medical Device Manufacturing

Employment Type: Full-Time

You'll play a critical role in ensuring the compliance, quality, and success of innovative medical device products that support healthcare organizations worldwide. This is an opportunity to join a collaborative, fast-paced manufacturing environment where your expertise directly influences product quality, regulatory readiness, and business growth.

• Make a meaningful impact on Class I and Class II medical device programs
• Work alongside cross-functional teams including Engineering, Quality, Manufacturing, and Supply Chain
• Gain exposure to evolving FDA and international regulatory requirements
• Be part of a company that values accountability, teamwork, and continuous improvement
• Opportunities for professional growth and long-term career development
• High-visibility role with significant influence on compliance and audit readiness
• Veteran-friendly workplace

Please note: This is a fully onsite position in Torrance, CA. Remote and hybrid arrangements are not available.

Privately held technology company within the medical device industry is seeking an experienced Regulatory Affairs Specialist to support medical device compliance activities, regulatory documentation, quality systems, and audit preparedness. The ideal candidate will have a strong experience in FDA-regulated environments and hands-on experience supporting quality and regulatory functions within the medical device industry.

This role will support Class I and Class II medical device programs, including technical documentation, design history files, change control processes, labeling review, supplier documentation, quality management systems, risk management activities, and regulatory audit readiness.

• Bachelor's Degree required in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical field

• Minimum 8-10 years of experience in:
  • Regulatory Affairs
  • Quality Assurance
  • Compliance
  • Medical Device Regulatory Operations

• FDA audit support and audit preparation
• Change control assessments and documentation
• Product labeling review and approval
• Quality Management System (QMS) administration and maintenance
• Experience working within FDA-regulated and ISO 13485 environments
• Regulatory documentation management for medical devices
• Design History Files (DHF) and Device Master Records (DMR)
• Strong knowledge of FDA 21 CFR Part 820 requirements
• Excellent documentation, communication, and organizational skills

• Support regulatory compliance activities for medical device products.
• Maintain and update regulatory documentation for Class I and Class II devices.
• Support Design History Files (DHFs), Device Master Records (DMRs), technical files, and regulatory evidence packages.
• Conduct regulatory assessments related to engineering and manufacturing change controls.
• Review and approve product labels, IFUs, specifications, drawings, procedures, and quality records.
• Support risk management activities in accordance with ISO 14971.
• Assist with internal, external, customer, and certification audits.
• Prepare audit documentation and ensure audit readiness across all regulated records.
• Partner with Engineering, Quality, Operations, Manufacturing, and Supply Chain teams to ensure compliance requirements are met.
• Maintain supplier regulatory documentation and compliance records.
• Support customer regulatory requests, questionnaires, compliance letters, and technical documentation packages.
• Ensure documentation is complete, controlled, accurate, and inspection-ready.

• Experience with Class II medical devices
• Support of FDA 510(k) submissions
• EU MDR technical documentation experience
• Knowledge of IEC 60601-1, IEC 62304, IEC 62366, and ISO 14971
• Experience within contract manufacturing or complex electromechanical manufacturing environments
• Experience supporting customer audits from major medical device OEMs

• Ability to sit or stand for extended periods
• Occasional walking throughout manufacturing and office facilities
• Ability to bend, reach, and climb stairs when necessary
• Ability to lift and carry up to 50 pounds without assistance
• Frequent use of computers, keyboards, phones, and display screens

Regulatory Affairs • Medical Devices • FDA Audits • Quality Assurance • Compliance • ISO 13485 • Change Control • Label Review • QMS • DHF • DMR • Audit Readiness • Regulatory Documentation • FDA 21 CFR Part 820 • Risk Management

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

The pay range for this position is $120000.00 - $150000.00/yr.

Compensation and Benefits • Salary Range: $120k - $150k (based on experience and qualifications) • Medical, vision and dental insurance • 401(k) with company match (100% of the first 4% in eligible compensation) • Flexible Spending Account • 2 weeks paid vacation • 1 Week sick pay • 10 company holidays • Group life insurance

This is a fully onsite position in Torrance,CA.

This position is anticipated to close on Aug 26, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.