Sr. Regulatory Affairs Specialist

Description

Position Summary We are seeking an experienced Regulatory Affairs professional to support global regulatory compliance and product lifecycle activities for a portfolio of medical devices. This individual will partner with cross-functional teams to develop regulatory strategies, prepare submissions, maintain product registrations, and ensure ongoing compliance with applicable international regulations. This role requires strong technical writing skills, regulatory knowledge, and the ability to manage multiple projects within a dynamic product development environment. Key Responsibilities Develop and execute regulatory strategies supporting new product introductions, product modifications, and ongoing regulatory maintenance activities. Prepare, review, and submit regulatory documentation to support product approvals, registrations, renewals, and market access activities in domestic and international markets. Maintain global product registrations and regulatory licenses in accordance with applicable regulatory requirements. Partner with Quality, Engineering, Clinical, Manufacturing, Marketing, and Product Development teams to ensure regulatory requirements are incorporated throughout the product lifecycle. Evaluate proposed product and process changes and provide regulatory guidance regarding submission requirements and compliance impact. Support regulatory agency interactions, including responses to inquiries, audit observations, and requests for additional information. Contribute to regulatory assessments related to design changes, product enhancements, and risk management activities. Review technical documentation, protocols, reports, labeling, and other records to ensure regulatory compliance and submission readiness. Support post-market regulatory activities including complaint investigations, vigilance reporting, field actions, and post-market surveillance programs. Ensure compliance with applicable product registration, labeling, UDI, and market-specific requirements. Support internal and external audits and inspections associated with quality and regulatory systems. Develop and maintain regulatory procedures, work instructions, and training materials. Monitor evolving regulatory requirements and communicate potential business impacts to stakeholders. Provide guidance and mentorship to less experienced regulatory team members as needed.

Skills

EU MDR, ISO 13485, MDSAP, registration, 510k, Medical device, technical file, Regulatory Affairs Certification, Regulatory submission, Regulatory affairs

Top Skills Details

EU MDR,ISO 13485,MDSAP

Additional Skills & Qualifications

Required Qualifications Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline. Minimum 5 years of experience in Regulatory Affairs within the medical device industry. Strong working knowledge of global medical device regulations and quality system requirements. Experience preparing and maintaining regulatory submissions and technical documentation for medical device products. Experience supporting international product registrations and market access activities. Working knowledge of quality management systems, risk management principles, and design control requirements. Demonstrated ability to interpret regulatory requirements and apply them to product development and commercialized products. Strong technical writing, project management, and organizational skills. Ability to manage multiple priorities and work effectively in a cross-functional environment. Strong verbal and written communication skills. Preferred Qualifications Advanced degree in a scientific, engineering, or regulatory discipline. Experience supporting international regulatory submissions and registrations across multiple regions. Knowledge of post-market surveillance, vigilance reporting, and product lifecycle management activities. Experience supporting clinical studies and regulatory aspects of clinical research programs. Familiarity with software-related medical device regulations and requirements. Regulatory Affairs Certification (RAC) or similar professional certification. Experience working with notified bodies, auditors, and global regulatory authorities. Technical Competencies Medical Device Regulations Global Product Registration Technical Documentation Design Controls Risk Management UDI and Labeling Compliance Post-Market Surveillance Quality Management Systems Change Control Regulatory Strategy Development Audit and Inspection Readiness Cross-Functional Project Leadership

Experience Level

Expert Level

This is a Permanent position based out of Westlake Village, CA.

The pay range for this position is $100000.00 - $130000.00/yr.

Medical, vision, dental, holiday, vacation, 401k and more

This is a fully onsite position in Westlake Village,CA.

This position is anticipated to close on Jul 31, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $100,000 - $130,000