DescriptionWe 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!
