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Manager/Director Regulatory Affairs - Pleasanton, CA (Pleasanton, CA)
In This Role, You Will
- Develop and implement regulatory strategies to obtain FDA clearances, approvals, and compliance for new and existing medical devices.
- Lead the preparation, submission, and maintenance of regulatory filings such as 510ks, letters to file, and responses to FDA queries.
- Participate in the planning of long-term product development programs and short-term projects
- Collaborate with marketing to review and approve product marketing claims, ensuring compliance with FDA regulations and guidelines.
- Act as a strategic partner to product development teams, providing regulatory guidance and input from the product concept phase through to product launch, ensuring products are designed and developed with regulatory compliance in mind.
- Collaborate with the medical and clinical teams to ensure clinical trial protocols align with regulatory requirements and assist in preparing regulatory submissions to support clinical trials and device approval.
- Collaborate with product development teams to review and approve product instructions for use and product labeling, including managing GTIN/UDI.
- Maintain current knowledge of U.S. and relevant global regulatory requirements and ensure company practices comply with applicable regulations and standards.
- Collaborate with the quality team to ensure that the company’s Quality Management System (QMS) meets regulatory requirements and is effectively implemented.
- Review complaint decision trees and handle regulatory reporting of events.
- Establish and maintain domestic and international registration and product listings.
- Participate in the risk management process, including health hazard assessments, product risk assessments, benefit-risk analysis, and reports required for the risk management file.
- Oversee and execute medical device reporting and advisory notice activities in accordance with applicable regulations and internal procedures.
- Participate in internal and external audits and inspections, including follow-up activities.
- Work closely with R&D, Quality, Marketing, Clinical, Market Access, and other departments to align regulatory activities with business objectives.
- General Counsel
- Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree preferred).
- 7+ years of experience in regulatory affairs within the medical device industry, with a focus on U.S. FDA submissions and clearances.
- Deep knowledge of FDA regulations and filings.
- Expertise in reviewing and approving marketing claims in compliance with regulatory guidelines.
- Proven track record of partnering with product development teams to provide regulatory input throughout the product lifecycle.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and collaboration skills, with the ability to influence cross-functional teams.
- Knowledge of international (OUS) regulatory processes preferred
- RAC (Regulatory Affairs Certification) preferred
- Travel: 5% travel may be required
- Full-time employment
- Must be able to sit for up to 8 hours/day
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