Principal Regulatory Affairs Specialist

Capstan Medical, Inc.•Santa Cruz, CA

3d•Onsite

About The Position

Capstan Medical is seeking a Principal Regulatory Affairs Specialist to support regulatory activities for its mitral and/or tricuspid valve products. The role supports global strategies and assigned regulatory submissions, projects, and requirements across geographies, while helping ensure product compliance. It also provides cross-functional guidance through product changes and approval in a fast-paced, evolving environment.

Requirements

Bachelor’s degree in Regulatory Science, Biomedical Engineering, Life Sciences, or a related technical discipline.
At least 6 years of progressive, successful regulatory affairs experience in the medical device industry.
Strong experience supporting submissions for high-risk, novel medical devices.
Familiarity with relevant medical-device regulatory requirements, including quality-system standards and clinical investigations.
Ability to work both collaboratively and independently in a fast-paced, changing environment.
Ability to leverage or engage others to accomplish projects.
Ability to multitask, prioritize, and meet deadlines.
Exercise sound and ethical judgment within company policies and worldwide regulations.

Nice To Haves

Experience with Class III long-term implantable devices, software, and/or robotics is preferred.

Responsibilities

In collaboration with Regulatory management, develop, assess, and implement global and regional strategies for product investigational use, commercialization, and lifecycle management.
Support, author, compile, and manage submissions to regulatory agencies, as assigned.
Evaluate proposed design, labeling, and manufacturing changes to determine necessary regulatory filings.
Support regulatory health authority communications to negotiate submission requirements and expedite pending registrations.
Support maintenance of annual licenses, registrations, and product listing information, where required.
Support maintenance of labeling and correct interpretation of current standard requirements into labeling.
Support internal and external regulatory and quality-system requirements, including ISO 13485, 21 CFR 820, and EU MDR.
Support internal and external regulatory and quality-system audits and serve as a subject matter expert during audits.
Support product release by reviewing and approving product release requests.
Support company initiatives identified by management and initiatives relating to Quality Management Systems, Environmental Management Systems, and other applicable regulatory requirements.
Complete other duties as assigned.