Director, Regulatory Affairs

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.