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Job Title: Regulatory Specialist

Job Description

As a Senior Regulatory Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. This role involves developing and authoring regulatory submissions, providing critical input on cross-functional project teams, and ensuring submissions comply with global regulations. The position is on-site and may require additional hours and/or travel as necessary to complete time-sensitive projects.

Responsibilities

+ Prepare, review, and submit regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies or distributors.

+ Develop regulatory strategies for new product submissions, modifications, and renewals to ensure compliance with local and international regulations.

+ Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.

+ Prepare, submit, and maintain regulatory licensing by jurisdictions.

+ Work cross-functionally with R&D, Quality, Clinical, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle.

+ Interface with regulatory agencies to respond to inquiries, deficiency letters, and audits in a timely and professional manner.

+ Maintain up-to-date knowledge of global regulatory requirements and assess their impact on current and future product approvals.

+ Support post-market surveillance activities, including adverse event reporting, vigilance reporting, and corrective/preventive actions.

+ Ensure compliance with labeling, UDI (Unique Device Identification), and registration requirements for applicable markets.

+ Assist in internal and external audits, including EU MDR, MDSAP, and country-specific inspections.

+ Develop and maintain regulatory procedures, work instructions, and training materials.

+ Provide guidance to junior regulatory team members as needed.

+ Work with a cross-functional team to provide regulatory support for new product introduction and existing products.

+ Create, review, and approve change requests.

+ Interpret new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.

+ Review protocols and reports to support regulatory submissions.

+ Maintain proficiency in global quality and regulatory requirements.

+ Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

+ Provide regulatory input to product lifecycle planning.

+ Provide support for clinical studies, including preparing and submitting regulatory documents, interacting between sites, supporting site requests, maintaining technical documentation, and all study files.

Essential Skills

+ Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.

+ 5-7 years of regulatory affairs experience in the medical device industry.

+ Strong understanding of EU MDR 2017/745, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other international medical device regulations.

+ Proven experience in preparing regulatory submissions such as Technical Files, STED (Summary Technical Documentation), CE Marking dossiers, 510(k) (if applicable), and country-specific submissions.

+ Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters.

Additional Skills & Qualifications

+ Experience with clinical studies.

+ Ability to work effectively on project teams.

+ Must be able to manage multiple and competing priorities and manage programs with minimal oversight.

+ Strong analytical and problem-solving skills.

+ Experience with medical device software requirements and software regulations.

+ Ability to identify risk areas and escalate issues as appropriate.

+ Prior direct involvement with product development teams.

+ Good understanding of product development process and design control.

+ Must be able to write clear, understandable technical documents, i.e., regulatory documentation and scientific presentations.

+ Experience in assembling facts from various areas, analyzing data, and providing informed recommendations.

+ Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance.

+ Organized, efficient, process-oriented, high attention to detail.

+ Effective interpersonal/communication skills.

+ Supporting products from initial concept through end-of-life phases.

+ Demonstrated MS Suite proficiency (e.g., Microsoft Word, Excel, Office, PowerPoint, and Adobe).

+ Regulatory Affairs Certification (RAC).

Work Environment

The work environment consists of office half cubicles adjacent to the manufacturing clean room

Pay and Benefits

The pay range for this position is $62.50 - $62.50/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)

Workplace Type

This is a fully onsite position in Agoura Hills,CA.

Application Deadline

This position is anticipated to close on May 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.