Director, Regulatory Affairs - Visualization

Work Flexibility: Hybrid

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.

Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.