Job Title: Regulatory Affairs Specialist

Job Description

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

Responsibilities

• Prepare and lead the completion of high-quality pre-market submissions.
• Review and verify documents/technical information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
• 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 base of existing regulations, standards, or guidance documents and proactively seek information to resolve questions related to assigned projects.
• Participate in project development teams and review plans, reports, risk management, risk assessments, and design reviews associated with product and process projects.
• 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/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

• Minimum of Bachelor's degree (preferably in a technical field such as engineering or medical) or equivalent education, training, and experience.
• Minimum of three (3) years of medical device regulatory and/or quality experience.
• Knowledge and experience of FDA 21 CFR Part 820 and 510(k) submission requirements.
• Knowledge of Canadian Medical Device Regulations, MDD, MDSAP, ISO standards, and filing regulatory submissions with Health Canada.

Additional Skills & Qualifications

• Experience in regulatory submission, FDA, and regulatory documents.
• Strong attention to detail and the ability to verify documents for errors, legibility, and missing information.
• Ability to maintain and disseminate knowledge of existing regulations, standards, or guidance documents.
• Experience in reviewing labeling and promotional material for compliance.

Work Environment

The work environment includes participation in project development teams, conducting regulatory reviews, and engaging in internal and external audits. The role involves maintaining databases, writing or updating standard operating procedures, and coordinating recall or market withdrawal activities as necessary.

Pay and Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Medical, Dental, Vision, 401k with company match, Vacation, Sick and Company Paid Holidays. Innovation Health focuses on providing employees with coordinated access to quality care through local neighborhood care, case managers, and engagement, aiming to keep them healthy, happy, and productive.

Workplace Type

This is a fully onsite position in Scottsdale,AZ.

Application Deadline

This position is anticipated to close on Mar 31, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $80,000 - $90,000