"Alerted.org

Job Title: Director of Regulatory AffairsJob Description

The Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support product development, registration, and post-market compliance of medical devices, including Software as a Medical Device (SaMD). The role involves managing a team of regulatory professionals and collaborating cross-functionally to ensure compliance with regulatory requirements across the United States, European Union, Canada, Australia, and Japan.

Responsibilities

+ Lead the preparation, submission, and management of regulatory filings for various global markets including the U.S., EU, Canada, Australia, and Japan.

+ Serve as the primary liaison with regulatory agencies, notified bodies, and authorized representatives.

+ Interpret and communicate regulatory requirements to internal teams, influencing product strategy and timelines.

+ Supervise, mentor, and develop a team of regulatory affairs professionals.

+ Assign responsibilities, manage workloads, and ensure timely and compliant execution of regulatory deliverables.

+ Promote a culture of continuous improvement, compliance, and regulatory excellence.

+ Provide regulatory input throughout the product lifecycle, including concept, design, development, verification, validation, and commercialization.

+ Participate in design reviews and ensure regulatory requirements are integrated into design inputs and outputs.

+ Review and approve regulatory aspects of design documentation, labeling, and marketing materials.

+ Support product risk management activities, including risk assessments and risk-benefit analyses.

+ Collaborate with Quality and Clinical teams to support complaint handling, adverse event reporting, field actions, and CAPA investigations.

+ Ensure appropriate regulatory reporting of post-market events.

+ Contribute to the development and maintenance of Post-Market Surveillance plans and reports.

+ Oversee regulatory strategy and compliance for SaMD products, including cybersecurity, validation, and documentation requirements.

+ Stay up to date with evolving regulatory frameworks for SaMD.

Essential Skills

+ Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; Master’s degree or RAC preferred.

+ 7+ years of regulatory affairs experience in the medical device industry.

+ At least 2 years of direct people management or team leadership experience.

+ Strong knowledge of 21 CFR 820, 807, 814, 812, EU MDR 2017/745, Health Canada Medical Devices Regulations, TGA and PMDA requirements.

+ Experience supporting design control, risk management, and post-market surveillance.

+ Proven ability to lead regulatory strategy discussions and manage agency interactions.

+ Exceptional communication, organizational, and project management skills.

Additional Skills & Qualifications

+ RAC Certification (US, EU, or Global) preferred.

+ Familiarity with MDSAP, IEC, and ISO standards.

+ Knowledge of quality management systems and regulatory intelligence tools.

+ Proficiency with regulatory submission software/tools (e.g., eCopy, CESP, RPS).

Work Environment

The position operates in a dynamic and fast-paced environment where cross-functional collaboration is essential. The role involves utilizing advanced regulatory submission software and tools and requires adherence to global regulatory standards. Dress code is business casual.

Pay and Benefits

The pay range for this position is $160000.00 - $180000.00/yr.

25% bonus potentialunlimited PTO

Workplace Type

This is a hybrid position in Valencia,CA.

Application Deadline

This position is anticipated to close on Aug 4, 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.