Principal Regulatory Affairs Specialist

Capstan Medical; California; Vor Ort; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision benefits

Flex time off

Zusammenfassung

Capstan Medical is seeking a Principal Regulatory Affairs (RA) Specialist to support regulatory activities for mitral and/or tricuspid valve products. You will guide global/regional regulatory strategies, manage submissions, and ensure compliance across geographies.

This fast-paced role requires collaboration, organizational skills, and adherence to regulatory standards. The role emphasizes partnering with cross-functional teams to navigate ISO 13485, 21 CFR 820, and EU MDR, while supporting

Qualifikationen

• Bachelor’s degree in Regulatory Science, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Minimum 6 years of progressive and successful regulatory affairs experience in the medical device industry; Class III long-term implantable, software, and/or robotics experience is preferred.
• Strong experience supporting submissions for high risk, novel medical devices.
• Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Ability to multitask, prioritize, and meet deadlines.

Aufgaben

• 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/quality system requirements (e.g., ISO 13485, 21 CFR 820, EU MDR).
• Support internal and external regulatory/quality system audits and Subject Matter Experts (SME) during the audits (e.g., ISO 13485, 21 CFR 820, EU MDR).
• Support product release process by reviewing and approving requests for product release.
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, as applicable.
• Complete other duties as assigned.

Kenntnisse

Regulatory affairs

Medical devices

Project management

Regulatory submissions

Team collaboration

Multitasking

Deadline management

Ausbildung

Bachelor's in Regulatory Science

Tools

Regulatory software

Jobbeschreibung

At Capstan Medical, we are driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we have pioneered a patient-optimized approach to repair and replace heart valves.

Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.

Capstan Medical is uniquely positioned in Santa Cruz, CA; this gives us access to the amazing technical talent of the Bay Area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.

Come join us and become part of a team revolutionizing heart valve treatment!

Description

We are seeking a Principal RA Specialist to support Regulatory activities for the Capstan mitral and/or tricuspid valve products. As the Principal RA Specialist, you will be responsible for supporting global strategies, assigned Regulatory submissions/projects/requirements in varying geographies, as assigned, and ensuring product compliance. The Principal RA Specialist also supports cross-functional team guidance through product changes and approval. The role is fast-paced and evolving, requiring excellent collaboration, organizational and project management skills.

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/quality system requirements (e.g., ISO 13485, 21 CFR 820, EU MDR).
• Support internal and external regulatory/quality system audits and Subject Matter Experts (SME) during the audits (e.g., ISO 13485, 21 CFR 820, EU MDR).
• Support product release process by reviewing and approving requests for product release.
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, as applicable.
• Complete other duties as assigned.

Requirements

• Bachelor’s degree in Regulatory Science, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Minimum 6 years of progressive and successful regulatory affairs experience in the medical device industry; Class III long-term implantable, software, and/or robotics experience is preferred.
• Strong experience supporting submissions for high risk, novel medical devices.
• Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Ability to multitask, prioritize, and meet deadlines.
• Exercise good and ethical judgment within company policies and worldwide regulations

Why join us

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.