Director of Regulatory Affairs

Spryte Medical • Bedford, MA

4d • $215,000 - $230,000

About The Position

Spryte Medical is seeking an experienced and strategic Director of Regulatory Affairs to lead the development and execution of global regulatory strategies supporting the Company's innovative medical device portfolio. This individual will be responsible for providing regulatory leadership across product development, clinical programs, commercialization, and lifecycle management while ensuring compliance with applicable global regulatory requirements. The Director of Regulatory Affairs will serve as a key strategic partner to executive leadership and cross-functional teams, driving regulatory initiatives that enable timely product approvals and market access. This role will lead regulatory agency interactions, oversee complex regulatory submissions, and provide expert guidance on evolving regulatory requirements impacting the business. As the organization grows, the Director will be responsible for building and developing the Regulatory Affairs function, including personnel leadership, resource planning, regulatory processes, and organizational capabilities. The successful candidate will thrive in a fast-paced environment, balancing strategic thinking with hands-on execution while helping shape the future of a pioneering medical device company.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.
• Minimum 12 years of progressive Regulatory Affairs experience within the medical device industry.
• Minimum 3-5 years of regulatory leadership experience with demonstrated responsibility for major regulatory programs and cross-functional teams.
• Direct experience leading FDA regulatory submissions including IDEs, De Novo Requests, PMAs, and/or 510(k)s.
• Direct experience with EU MDR and international regulatory frameworks.
• Demonstrated success developing and executing regulatory strategies for complex medical devices.
• Extensive knowledge of: FDA regulations, EU MDR, ISO 13485, Design Controls, Risk Management, Clinical Evidence Requirements, Medical Device Software Regulations.
• Strong regulatory writing, negotiation, and communication skills.
• Proven ability to influence decision-making at all organizational levels.
• Experience working effectively within fast-paced startup or growth-stage environments.

Nice To Haves

• Advanced degree (MS, MPH, MBA, PhD, or equivalent).
• RAC (Regulatory Affairs Certification).
• Experience with Class III and neurovascular medical devices.
• Experience supporting pivotal IDE studies and associated regulatory interactions.
• Experience obtaining De Novo classification and/or PMA approval.
• Experience leading FDA and Notified Body inspections.
• Prior responsibility for building and scaling Regulatory Affairs functions.

Responsibilities

• Develop and execute global regulatory strategies supporting product development, clinical investigations, commercialization activities, and lifecycle management.
• Serve as the regulatory representative on cross-functional project teams, ensuring regulatory requirements and expectations are incorporated throughout the product development process.
• Provide strategic regulatory guidance to Executive Management, Clinical Affairs, Customer Experience, Quality Assurance, Engineering and Manufacturing.
• Evaluate regulatory pathways and associated risks, opportunities, timelines, and resource requirements for new products and product modifications.
• Lead regulatory planning for novel technologies and complex regulatory pathways, including De Novo, PMA, 510(k), IDE, EU MDR, and international market authorizations.
• Develop and implement scalable regulatory processes, systems, and procedures to support organizational growth and operational excellence.
• Monitor regulatory performance metrics and drive continuous improvement initiatives.
• Lead the preparation, review, and submission of complex regulatory applications, including: Investigational Device Exemptions (IDEs), De Novo Requests, 510(k) Premarket Notifications, Premarket Approval (PMA) Applications, PMA Supplements, EU MDR Technical Documentation, Health Canada Medical Device License Applications, PMDA Submissions.
• Oversee regulatory submission timelines, resource planning, and execution activities.
• Serve as the primary regulatory liaison with FDA, Notified Bodies, Competent Authorities, and other global regulatory agencies.
• Lead regulatory authority meetings, including Q-Subs, Pre-Subs, panel interactions, and notified body consultations.
• Coordinate and prepare responses to regulatory agency questions, deficiency letters, and requests for additional information.
• Support inspections, audits, and regulatory inquiries.
• Partner with Clinical Affairs, Quality, and Engineering to define regulatory requirements supporting design verification, validation, risk management, usability engineering, and clinical evidence generation.
• Assess regulatory impact of design changes, manufacturing changes, labeling updates, software modifications, and process improvements.
• Develop regulatory strategies supporting product enhancements, new indications, and geographic market expansion.
• Ensure regulatory requirements are appropriately integrated into design control and change management processes.
• Review and approve product labeling, promotional materials, and claims to ensure regulatory compliance.
• Maintain a thorough understanding of applicable regulations and standards, including: FDA regulations and guidance documents, EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 62366, Applicable international regulations and standards.
• Monitor emerging regulatory requirements and industry trends.
• Provide regulatory impact assessments and strategic recommendations to leadership regarding evolving regulatory landscapes.
• Support quality system compliance and integration of regulatory requirements across the organization.
• Ensure regulatory files, product registrations, and supporting documentation are maintained appropriately.
• Build, mentor, and develop a high-performing Regulatory Affairs team.
• Establish departmental goals, objectives, and performance metrics aligned with company priorities.
• Provide leadership and regulatory expertise to cross-functional teams and organizational initiatives.
• Manage external consultants, regulatory contractors, and global regulatory partners as needed.
• Foster a culture of compliance, accountability, strategic thinking, and continuous improvement.

Benefits

• Spryte Medical is an Equal Opportunity Employer committed to building a diverse and inclusive workplace where everyone is respected, valued, and has the opportunity to succeed.
• We make all employment decisions based on qualifications, merit, and business needs, and do not discriminate on the basis of race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.
• We are committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants throughout the hiring process. If you require accommodation to participate in the application or interview process, please let us know.

What This Job Offers

• Job Type: Full-time
• Career Level: Director