Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Direct Hire Full-Time Role

Salary Range: $129,000 - $147,000 per year

Location: Santa Clara, CA - Hybrid Role

Duties and Responsibilities:

• Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical Files, international submissions).
• Maintain existing regulatory approvals, clearances, and documentation.
• Manage regulatory projects aligned with key strategic and commercial initiatives.
• In cases of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, ISO 14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing and must report instances to their supervisor.
• Conduct all business in a strictly honest, ethical, and legal manner, in compliance with the Code of Conduct, company policies, the AdvaMed Code, and all applicable laws and regulations.
• Support New Product Development teams as the regulatory representative; develop and implement regulatory strategies and deliverables for US, EU, and international markets.
• Collaborate with the Head of Regulatory on communications and correspondence with the FDA, EU Notified Bodies, and other regulatory authorities.
• Prepare regulatory submissions including US Pre-Submissions, 510(k)s, Letters-to-File, EU/OUS Declarations of Conformity, Technical Files (STEDs), and Notices of Change.
• Review product changes to assess impact on current clearances and approvals.
• Implement new or updated regulatory requirements, including changes related to EU MDR.
• Participate in internal and external audits/inspections in a regulatory capacity; support the resolution of findings and Quality System Management Representative as appropriate.
• Facilitate communication and remediation activities related to regulatory findings; prepare written audit responses to regulatory agencies.
• Oversee labeling, including product labels, implant cards, IFUs, surgical technique guides, and cleaning/sterilization instructions, ensuring compliance with regulations and standards. Ensure translations meet in-country requirements.
• Communicate with regulatory consultants (e.g., Emergo), Authorized Representatives, and international authorities to secure approvals and manage registrations.
• Monitor competitor FDA clearances/approvals and proactively share insights internally.
• Support sustaining activities, including product changes, supplier changes, CAPAs, deviations, NMRs, and scope extensions.
• Write and/or review SOPs, work instructions, and forms impacting the Quality Management System (QMS).
• Support and maintain the QMS.

Requirements and Qualifications:

• A bachelor's degree in a scientific discipline is required.
• 6+ years of directly relevant experience, including a minimum of 5 years in the medical device industry (FDA, cGMP, CE Mark, or other regulated environments).
• Strong knowledge of industry standards and regulations (FDA, QSRs, MDR, ISO 13485, MEDDEV, MDCG, etc.).
• Experience with Quality System requirements, including Design Controls, Process Controls, Supplier Controls, CAPA, and Non-Conformances.
• Demonstrated regulatory experience preparing Pre-Submissions, 510(k)s, and STEDs.
• Excellent oral and written communication, organizational, and computer skills, including proficiency in Microsoft Office and Adobe Acrobat (FDA eCopy preparation).
• Thorough understanding of FDA and international medical device regulations, product development processes, and design control requirements.
• Ability to work independently with minimal supervision while managing multiple projects.
• Strong team player with a collaborative mindset.

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