Regulatory Affairs Specialist

Job Title: Regulatory Affairs SpecialistJob Description The Regulatory Affairs Specialist is responsible for preparing and submitting documentation for pre-market submissions, including FDA 510(k) submissions and Health Canada Medical Device License Applications. This role also supports post-market regulatory compliance activities. Responsibilities + Prepare and submit appropriate documentation for pre-market submissions, such as FDA 510(k) submissions and Health Canada Medical Device License Applications. + Support post-market regulatory compliance activities. + 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. Essential Skills + Minimum of three (3) years of medical device regulatory and/or quality experience. + In-depth knowledge and experience of FDA 21 CFR Part 820 and 510(k) submission requirements. + Familiarity with Canadian Medical Device Regulations, MDD, and MDSAP. + Experience with ISO standards and filing regulatory submissions with Health Canada. Additional Skills & Qualifications + Experience with regulatory compliance and labeling. + Ability to handle regulatory documents effectively. Work Environment The position requires onsite work from Monday to Friday, 8 AM to 5 PM. The company fosters a close-knit and entrepreneurial culture, offering full project ownership. Job Type & Location This is a Permanent position based out of Scottsdale, AZ. Pay and Benefits The pay range for this position is $80000.00 - $95000.00/yr. Employee benefitsHealth insurance: Medical and prescription drug coverage through Aetna.Dental and vision insurance: Coverage is provided through Delta Dental.Insurance: Includes life insurance, Accidental Death and Dismemberment (AD&D), and short and long-term disability through Reliance Standard.Paid time off: Includes vacation and sick leave.401(k): A retirement savings plan is available. Additional perks and employee experiencesWork environment: Reviews frequently mention a friendly and family-like work atmosphere.Food: Some employees report receiving free lunches on Fridays.Flexibility: some roles may offer flexible schedulesBonuses: Some employees have received company bonuses Workplace Type This is a fully onsite position in Scottsdale,AZ. Application Deadline This position is anticipated to close on Nov 26, 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. 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.