Stryker
Director, Regulatory Affairs
Stryker, San Jose, California, United States, 95199
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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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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.
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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.