Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for preparing and submitting the appropriate documentation for pre-market submissions, such as FDA 510(k) submissions and Health Canada Medical Device License Applications. This role also supports post-market regulatory compliance activities.

Responsibilities :

• Write and lead the completion of high-quality pre-market submissions.
• Review and verify documents and technical information for regulatory submissions from various functional areas, ensuring accuracy and completeness.
• Review and approve protocols and reports to support regulatory submissions.
• Prepare or assist with preparation of additional information or responses as requested by regulatory agencies.
• Maintain and disseminate current knowledge of existing regulations, standards, or guidance documents, and proactively seek information to resolve project-related questions.
• Participate in project development teams, reviewing plans, reports, risk management, risk assessments, and design reviews.
• Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities.
• Conduct regulatory review and approval of change orders, CAPA / nonconformance, and related project documentation.
• Review labeling and promotional material to ensure compliance with applicable regulations and policies.
• Implement and maintain unique identifier (UDI) activities for compliance.
• Assist with PFMEA risk assessments.
• Review complaints and adverse events for assessment of reportability and submission of MDRs if appropriate.
• Assist in archiving regulatory documentation and maintaining related databases.
• Participate in internal and external audits.
• Write or update standard operating procedures, work instructions, or policies.
• Assist with coordinating recall or market withdrawal activities as necessary.
• Perform other duties as assigned.

Essential Skills :

Additional Skills & Qualifications :

Work Environment :

This is an onsite position with working hours from Monday to Friday, 8 AM to 5 PM. The company promotes a close-knit culture with an entrepreneurial spirit, providing full project ownership.

Job Type & Location :

This is a Permanent position based out of Scottsdale, Arizona.

Pay and Benefits :

The pay range for this position is $80000.00 - $95000.00 / yr. Employee benefits include health insurance, dental and vision insurance, life insurance, AD&D, short and long-term disability, paid time off, and a retirement savings plan.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.

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.