Director, Regulatory Affairs

3 weeks ago

San Carlos, United States CareerBuilder Full time

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 Medicals 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 memberss 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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