Job Summary:
The Principal Regulatory Affairs (RA) Specialist will collaborate with cross-functional teams to support the Regulatory Affairs department and ensure adherence to regulatory compliance requirements. This role involves maintaining alignment with the company’s Quality Management System (QMS) while contributing to regulatory strategies and submissions. The Principal RA Specialist will also provide regulatory assessments for design control projects, document changes, and risk management, ensuring all activities comply with applicable regulatory bodies.

Key Responsibilities:

• Collaborate with R&D and Operations teams to define regulatory requirements throughout product development and manufacturing processes.
• Provide support for product verification and validation activities, including packaging, sterilization, transit testing, and aging studies. Review and approve engineering protocols and reports.
• Oversee risk management activities, including review and approval of Risk Management Files.
• Prepare regulatory submissions for Class III medical devices, including IDEs, PMAs, and international regulatory filings.
• Evaluate and approve document change orders (DCOs), design change requests, and product labeling for regulatory impact.
• Notify relevant regulatory bodies of any required changes and maintain communication regarding regulatory notifications.
• Review clinical event reports during studies, ensuring proper documentation and evaluation for regulatory reporting.
• Provide regulatory sign-off on product releases and shipments.
• Participate in internal and external audits, driving issue resolution and ensuring compliance.
• Ensure that product packaging and labeling comply with applicable regulatory standards.
• Maintain regulatory documentation, registrations, and listings for both domestic and international markets.
• Interpret and communicate regulatory requirements through company policies and procedures.
• Stay current with domestic and international regulatory guidelines, applying them to business processes.
• Write and revise department Standard Operating Procedures (SOPs) as needed.
• Provide mentorship to junior regulatory personnel.
• Comply with company quality system requirements and applicable health and safety regulations.
• Other duties as assigned.

Qualification Requirements:

Experience:

• Minimum 10 years of experience in Regulatory Affairs, with at least 8 years involving advanced qualifications such as a Master’s degree.
• 5+ years of experience within the medical device industry, particularly with Class III active devices.
• Regulatory Affairs certification preferred.
• Experience in design controls, including mechanical, software/firmware, and risk management review.
• Proven experience with FDA IDE and PMA submissions, as well as international regulatory filings.

Skills and Abilities:

• Strong knowledge of regulatory frameworks such as FDA (21 CFR 812, 820), ISO 13485, and ISO 14971.
• Thorough understanding of both domestic and international regulatory standards.
• Excellent written and verbal communication skills, with proficiency in technical writing and editing.
• Ability to analyze data, write clear technical documents, and manage multiple projects with precision.
• Strong problem-solving skills, attention to detail, and ability to work independently.
• Effective teamwork and interpersonal communication skills.

Education:

• Bachelor’s degree in Engineering, Science, or a related field.

Physical Demands:

• Combination of sitting, standing, and walking.
• Ability to occasionally lift up to 50 pounds.