Director, Regulatory Affairs - Military Veterans

The Director, Regulatory Affairs is a key strategist, responsible for developing regulatory strategy for the Endoscopy business unit and delivering Stryker’s best-in-class Visualization products to market in the United States, Canada and Europe. Through close partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Director will develop and advise on product positioning, product entry and exit strategies, among others. This leader will be responsible for a team of 4 direct reports and total team of 10.

This leader is required to be based in San Jose, CA with a hybrid work schedule of three days per week in office. Relocation support can be provided.

Key Areas of Responsibility:

• Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence


• Recognized as thought leader in advocacy activities


• Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes


• Accesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategy


• Integrates regulatory considerations into the organization's global product entry and exit strategy


• Identifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical products


• Manages negotiations with regulatory authorities on complex issues throughout the product lifecycle


• Influences changing regulations and guidance


• Interfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distribution


• Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs


• Leads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycle


• Leads the development and execution of good regulatory practices and policy


• Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products


• Leads the regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during preapproval/clinical phases


• Participates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessment


• Approves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changes


• Reviews and approves publicly disseminated information on product submission approval status


• Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets


• Implement regulatory system changes to support evolving regulations and international standards


• Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities


• Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission


• Establish standard process to ensure appropriate resolution and management of the responsible task owner


• Chair meetings required to drive closure of regulatory issues


• Manage and provide updates for regulatory metrics. Implement appropriate enhancements


• Represent regulatory processes during internal and external audits


• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets


• Recruit, select, and on-board top talent


• Develop talent within team to increase performance. Actively address performance issues on team


• Maintain a high level of team engagement


• Participate in advocacy activities of a more advanced strategic nature

Education / Work Experience:

• Bachelor’s degree in engineering or other relevant field of study


• Master's Degree or equivalent preferred


• Minimum of 10 years’ experience required


• RAC desired

Knowledge / Competencies:

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements


• Demonstrated expertise in regulatory systems in a regulated environment


• Demonstrated project management skills


• Demonstrated verbal, written, and interpersonal communication skills


• Demonstrated ability to work in a team environment, interact effectively with management from other functions


• Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets


• Demonstrated ability to initiate work


• Demonstrated analytical ability


• Demonstrated ability to make effective decisions


• Experience with recruiting, people development


• Influence across the organization

$189,400 – $321,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.