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Manager, Clinical & Regulatory Affairs

Job

Tethered Talent

Fremont, CA (In Person)

Full-Time

Posted 6 days ago (Updated 1 hour ago) • Actively hiring

Expires 8/11/2026

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Job Description

Manager, Clinical & Regulatory Affairs at Tethered Talent Manager, Clinical & Regulatory Affairs at Tethered Talent in Fremont, California Posted in 1 day ago.
Type:
full-time
Job Description:
This role reports to the VP of Clinical & Regulatory Affairs and will lead clinical studies, manage regulatory submissions, and partner cross-functionally to drive compliant, successful outcomes. Key Responsibilities Clinical Lead assigned clinical studies end-to-end, including protocols, submissions, site-readiness packages, study registration, and monitoring Manage clinical site relationships to ensure effective enrollment and operational execution Ensure compliance with GCP, ICH, and ISO guidelines across all assigned studies Provide leadership on clinical compliance, investigational device documentation, and audit/inspection readiness Collaborate cross-functionally to support planning and execution of clinical programs Regulatory Lead preparation and submission of regulatory filings including 510(k), PMA, renewals, amendments, and agency correspondence Support communications with global regulatory authorities Oversee regulatory documentation systems for complete, accurate record-keeping Develop and optimize internal regulatory processes, SOPs, and audit readiness programs Monitor evolving regulatory requirements and advise internal stakeholders Collaborate with R D, Clinical, Quality, and Commercial teams to ensure regulatory alignment Qualifications BS or higher in Biology, Bioengineering, or related scientific field 8+ years of clinical and regulatory experience, including leadership across multiple clinical trials resulting in regulatory submissions and approvals Deep knowledge of
GCP, ICH
guidelines, and global medical device regulatory frameworks Strong understanding of regulatory standards, labeling/claims, device-change guidelines, and premarket submission pathways Ability to travel up to 50% Medical Device experience Preferred Skills Strong verbal and written communication Proven ability to manage complex projects, mentor junior staff, manage budgets, and meet critical timelines Track record of successful marketing authorization submissions and commercial launch support Demonstrated leadership and cross-functional collaboration