Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Pay Rate: $120,000 – $150,000 annually

Employment Type: Direct Hire

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

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.

• 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

• 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
• Strong understanding of FDA 21 CFR Part 820 and ISO 13485 requirements
• Experience with technical documentation, change control, labeling review, and audit preparation
• 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, Net Suite, Master Control, Greenlight Guru, Arena, or similar platforms preferred

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

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.