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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Desired Skills and Experience

Regulatory submissions, 510(k) preparation, CE Mark technical files, international regulatory submissions, regulatory strategy, regulatory project management, FDA QSR compliance, ISO 13485, ISO 14971, IEC 62366, EU MDR, MEDDEV, MDCG, quality management systems, design controls, process controls, supplier controls, CAPA management, non-conformances, product change assessment, labeling compliance, IFU development, sterilization instructions, technical file preparation, STEDs, FDA eCopy, audit participation, audit remediation, regulatory correspondence, FDA communications, EU notified body communications, global regulatory approvals, competitor regulatory monitoring, SOP writing, work instruction development, QMS maintenance, cross-functional collaboration, new product development support, regulatory risk assessment, ethical and legal compliance, Microsoft Office proficiency, Adobe Acrobat proficiency, strong written and verbal communication, organizational skills, project management, ability to work independently, team collaboration