Job Description

Senior Regulatory Specialist

In your role as a Sr. Regulatory Specialist , you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our client's Westlake Village location and may require additional hours and/or travel as necessary to complete time-sensitive projects.

Key Responsibilities:

• Prepare, review, submit, and provide regulatory input and guidance to cross-functional partners for regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/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, ISO 13485, 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. Work with quality, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• 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, such as preparing and/or submitting regulatory documents, interaction between sites, support site requests, technical documentation, maintenance of all study files.
• Responsibilities may include the following and other duties may be assigned.

Minimum Requirements:

• 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.

Desired 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).

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