Regulatory Specialist Sr

Job Description

Job Description

Job Title: Regulatory Specialist Sr Job Description

The Regulatory Specialist Sr plays a key role in ensuring timely approval of new medical devices and maintaining continued approval of marketed products. This non-exempt position focuses on regulatory change assessments, medical device submissions, and participation in regulatory strategy and continuous improvement activities. The role serves as a regulatory representative on cross-functional teams, advising on manufacturing changes, line extensions, technical labeling, and the application of appropriate regulations and interpretations.

• Perform highly complex regulatory change assessments to evaluate the impact of product and process changes on regulatory approvals and compliance.
• Ensure timely approval of new medical devices by preparing, reviewing, and supporting regulatory submissions, primarily for the United States.
• Maintain continued approval and compliance of marketed medical device products through ongoing regulatory monitoring and documentation.
• Serve as the regulatory representative on cross-functional teams, providing guidance and expertise during product development, implementation, and lifecycle management.
• Participate in continuous improvement activities related to regulatory processes, documentation, and compliance practices.
• Contribute to product plan development and implementation from a regulatory perspective, ensuring alignment with applicable requirements and standards.
• Support the creation and execution of regulatory strategies that enable efficient market access and sustainable compliance for medical devices.
• Participate in risk management activities by assessing regulatory risks associated with product changes, submissions, and market activities.
• Support regulatory policy and intelligence efforts by monitoring relevant regulations, standards, and guidance documents, and communicating their impact to stakeholders.
• Advise development and marketing teams on manufacturing changes, line extensions, and technical labeling to ensure adherence to appropriate regulations and regulatory interpretations.
• Collaborate with internal stakeholders to ensure regulatory compliance is integrated into product design, development, and commercialization activities.
• Maintain accurate and complete regulatory documentation and records in accordance with internal procedures and external requirements.

• Minimum of 7 years of experience in Medical Device Regulatory Affairs.
• Extensive experience and high proficiency in regulatory change assessments for medical devices.
• Working knowledge of United States medical device submissions and related regulatory pathways.
• Strong understanding of regulatory compliance principles and practices for medical devices.
• Ability to serve effectively as a regulatory representative on cross-functional teams.
• Capability to advise on manufacturing changes, line extensions, and technical labeling in alignment with applicable regulations.
• Skill in interpreting and applying relevant medical device regulations, standards, and guidance documents.
• Experience participating in regulatory strategy development and implementation.
• Experience contributing to risk management activities from a regulatory perspective.
• Strong written and verbal communication skills for conveying regulatory requirements and recommendations to diverse stakeholders.
• Attention to detail and accuracy in preparing and reviewing regulatory documentation.

• Experience participating in continuous improvement initiatives related to regulatory processes and documentation.
• Background in product plan development and implementation with an emphasis on regulatory considerations.
• Exposure to regulatory policy and intelligence activities, including monitoring regulatory changes and assessing their impact.
• Ability to collaborate effectively with development and marketing teams to align regulatory requirements with business objectives.
• Strong organizational skills and the ability to manage multiple regulatory activities and priorities simultaneously.

This role operates within a professional medical device regulatory environment that emphasizes collaboration with cross-functional teams such as development, marketing, and quality. Work is primarily office-based, involving extensive use of computers and regulatory information systems to prepare, review, and manage submission documents and compliance records. The position focuses on United States medical device regulations and requires regular interaction with internal stakeholders to support product planning, risk management, and continuous improvement activities. The work setting values accuracy, thorough documentation, and clear communication, with a culture that supports ongoing learning in regulatory policy and intelligence.

This is a Contract position based out of Alameda, CA.

The pay range for this position is $54.00 - $54.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Alameda,CA.

This position is anticipated to close on Aug 19, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.