Director, Regulatory Affairs
2 weeks ago
The Director, Regulatory Affairs’ primary responsibility is to lead the Regulatory Affairs team in developing and implementing regulatory strategies and procedures. This role will lead regulatory strategy and submissions and provide regulatory guidance to the research and development teams during product development to ensure compliance with regulatory requirements. This is both a hand-on and a strategic position where your leadership and expertise will have a direct impact on patient safety, device quality, and the overall success of our company.
A Day In The Life Of Our Sr. Director, Regulatory Affairs
:
Develop and execute a comprehensive regulatory strategy to secure timely approvals for our robotic systems and devices both in the US and International Markets.
Serve as a key member of the senior leadership team, responsible for overall management of regulatory activities in support of Noah Medical’s growth objectives.
Work closely with cross-functional teams, including R&D, Clinical Affairs, Quality, and Legal, to align regulatory activities with business objectives.
Define and implement regulatory strategies, procedures, and controls for new products and/or business activities that require regulatory approvals.
Ensure successful submissions to the FDA and other global regulatory authorities, overseeing the preparation and submission of regulatory filings; including but not limited to Technical Documents, Q-Subs, IDEs, 510(k)s, and Non-filing justifications.
Stay up-to-date with evolving regulatory requirements, guidelines, and trends in the medical device industry.
Interpret regulations, laws, and guidance and establish, implement and monitor policies, procedures and processes to ensure compliance.
Recruit, hire, and onboard regulatory professionals with diverse skill sets, cultivating a high-performing team.
Provide ongoing coaching, guidance, and professional development opportunities to enhance team members’s regulatory expertise.
Overseeing and participating in the review and approval of design V&V activities, ensuring they adhere to regulatory requirements.
Collaborating closely with R&D and Quality teams to maintain rigorous V&V processes that demonstrate product safety and effectiveness.
Evaluating the impact of design changes on regulatory compliance and strategy, providing informed recommendations for the most appropriate regulatory pathway.
Demonstrating a deep understanding of both US FDA regulations (i.e. 21 CFR
820.21
and CFR 807) and international regulations and standards (e.g. ISO 13485, EUMDR) to inform decision making.
Proactively address and mitigate regulatory risks, guiding the company towards consistent compliance and best practices.
Leading the review and approval of marketing collateral, product labels and labeling ensuring regulatory compliance and accurate representation of product capabilities.
Work directly with regulatory agencies on regulatory issues and submissions
Lead regulatory inspections/audits by internal and external audit authorities
Lead international product registrations and licensing documentation
About You:
Proven leader with a minimum of 15 years of experience in regulatory affairs and related technical documentation for complex medical devices including software, hardware, and disposable components.
Excellent management abilities, minimum of 8 years of experience in leading regulatory teams
Demonstrated ability to build and lead effective, collaborative teams and empower team members
Extensive working knowledge of the US and global regulatory framework and their relevant governing authorities.
Proven accomplishments in developing and executing regulatory strategies resulting in product approvals in both US and International Markets.
Extensive experience in submissions including but not limited to technical documents, Q-subs, 510(k), and IDE submissions
Demonstrated strategic thinking ability and adaptability, to successfully navigate dynamic regulatory landscapes
Strong understanding of design controls with experience in verification and validation methods and documentation
Exceptional communication, negotiation, and relationship-building skills, enabling effective influence of stakeholders both internal and external. Strong interpersonal skills and ability to manage, develop and mentor personnel
Experience working in a startup environment
Workplace Type: Onsite
Benefits & Perks (For Full Time Employees):
Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
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