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Regulatory Affairs Specialist

Actalent -
Torrance, CA

Quick Apply

Job Details

Full-time
$120,000 - $150,000 a year
3 days ago

Benefits

Health insurance
Dental insurance
Flexible spending account
Vision insurance
401(k) matching
Life insurance
Paid sick time

Qualifications

Labeling
Compliance audits & assessments
Quality control audit
Medical device manufacturing facility experience
Compliance documentation
Regulatory readiness in healthcare
Internal compliance assessments
Regulatory/legal compliance standards in production
Quality standards in production
Biomedical regulatory compliance
Quality audits
Quality control records management
ISO 13485
Audit support

Full Job Description

JOB POSTING: Regulatory Affairs Specialist

Location: Torrance, CA (Onsite)

Industry: Medical Device Manufacturing

Employment Type: Full-Time

Join a Company Where Your Regulatory Expertise Makes an Impact

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.

Why Join Our Company?

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.

Position Summary

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.

Required Qualifications

Education

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

Experience

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

Must-Have Experience & Skills

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

Key Responsibilities

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.

Preferred Qualifications

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

Physical Requirements

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

Keywords

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

Job Type & Location

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

Pay and Benefits

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

Workplace Type

This is a fully onsite position in Torrance,CA.

Application Deadline

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 [email protected] 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.

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