Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Pay Rate: $120,000 – $150,000 annually
Location: Torrance, CA
Schedule: Onsite – 5 Days per Week
Employment Type: Direct Hire

Key Requirements

To be considered for this opportunity, candidates must have:

• Medical device industry experience
• ISO 13485 experience
• Regulatory affairs or quality compliance experience in FDA-regulated environments

Position Overview

We are seeking an experienced Regulatory Affairs Specialist to support medical device compliance activities, regulatory documentation, and quality system requirements. This role will support Class I and Class II medical device programs, including technical documentation, change control, risk management, labeling review, audit readiness, and regulatory compliance initiatives.

The ideal candidate will have experience working within FDA-regulated and ISO 13485-certified environments and possess strong documentation and cross-functional collaboration skills.

Responsibilities

• Support regulatory compliance activities for medical device products
• Maintain and update regulatory documentation
• Assist with Design History Files (DHF), Device Master Records (DMR), and Technical Files
• Support FDA 21 CFR Part 820/QMSR and ISO 13485 compliance efforts
• Review product labeling, specifications, procedures, and quality records
• Support risk management activities in accordance with ISO 14971
• Participate in change control assessments and regulatory impact reviews
• Support internal, external, customer, and certification audits
• Collaborate with Engineering, Quality, Manufacturing, Supply Chain, and Program Management teams
• Assist with FDA, EU MDR, and international regulatory documentation requests
• Prepare customer questionnaires, compliance letters, and technical documentation packages
• Maintain supplier regulatory documentation and compliance records
• Ensure documentation remains complete, accurate, and audit-ready

Qualifications

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline
• 8–10 years of Regulatory Affairs, Quality Assurance, or Compliance experience within the medical device industry
• Hands-on experience supporting Class I medical devices
• Strong understanding of FDA 21 CFR Part 820 and ISO 13485 requirements
• Experience with technical documentation, change control, labeling review, and audit preparation
• Class II medical device experience preferred
• Experience supporting 510(k) submissions, EU MDR, or international registrations preferred
• Familiarity with ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366 preferred
• Experience with eQMS/ERP systems such as QT9, NetSuite, MasterControl, Greenlight Guru, Arena, or similar platforms preferred

Skills

• Exceptional attention to detail and documentation accuracy
• Strong organizational and project management skills
• Excellent written and verbal communication skills
• Ability to work effectively across multiple departments
• Self-motivated and capable of managing competing priorities
• Proficiency with Microsoft Office Suite, including Excel

Compensation & Benefits

• Salary: $120,000 – $150,000 annually
• Medical, Dental, and Vision Insurance
• 401(k) with Company Match
• Flexible Spending Account (FSA)
• Paid Vacation
• Paid Sick Leave
• Company Holidays
• Group Life Insurance

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.

Pay: $120,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Application Question(s):

• Do you have at least 8 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within the medical device industry?
• Have you supported Class I or Class II medical devices, including regulatory documentation, change control, labeling review, or audit preparation?
• Do you have experience with FDA 21 CFR Part 820/QMSR and medical device quality systems?
• Do you have hands-on experience working in FDA-regulated environments and supporting ISO 13485 compliance requirements?

Education:

• Bachelor's (Required)

Work Location: On the road

Salary : $120,000 - $150,000