Stryker
Director, Regulatory Affairs
Stryker, San Jose, California, United States, 95199
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.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 intelligenceRecognized as thought leader in advocacy activitiesDevelops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changesAccesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategyIntegrates regulatory considerations into the organization's global product entry and exit strategyIdentifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical productsManages negotiations with regulatory authorities on complex issues throughout the product lifecycleInfluences changing regulations and guidanceInterfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distributionLeads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needsLeads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycleLeads the development and execution of good regulatory practices and policyProvides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical productsLeads 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 phasesParticipates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessmentApproves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changesReviews and approves publicly disseminated information on product submission approval statusReview regulatory compliance requirements for changes affecting product submission and device manufacturing in global marketsImplement regulatory system changes to support evolving regulations and international standardsProvide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activitiesEnsure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company missionEstablish standard process to ensure appropriate resolution and management of the responsible task ownerChair meetings required to drive closure of regulatory issuesManage and provide updates for regulatory metrics. Implement appropriate enhancementsRepresent regulatory processes during internal and external auditsDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targetsRecruit, select, and on-board top talentDevelop talent within team to increase performance. Actively address performance issues on teamMaintain a high level of team engagementParticipate in advocacy activities of a more advanced strategic natureEducation / Work Experience:Bachelor’s degree in engineering or other relevant field of studyMaster's Degree or equivalent preferredMinimum of 10 years’ experience requiredRAC desiredKnowledge / Competencies:Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirementsDemonstrated expertise in regulatory systems in a regulated environmentDemonstrated project management skillsDemonstrated verbal, written, and interpersonal communication skillsDemonstrated ability to work in a team environment, interact effectively with management from other functionsDemonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targetsDemonstrated ability to initiate workDemonstrated analytical abilityDemonstrated ability to make effective decisionsExperience with recruiting, people developmentInfluence 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.
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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 intelligenceRecognized as thought leader in advocacy activitiesDevelops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changesAccesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategyIntegrates regulatory considerations into the organization's global product entry and exit strategyIdentifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical productsManages negotiations with regulatory authorities on complex issues throughout the product lifecycleInfluences changing regulations and guidanceInterfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distributionLeads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needsLeads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycleLeads the development and execution of good regulatory practices and policyProvides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical productsLeads 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 phasesParticipates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessmentApproves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changesReviews and approves publicly disseminated information on product submission approval statusReview regulatory compliance requirements for changes affecting product submission and device manufacturing in global marketsImplement regulatory system changes to support evolving regulations and international standardsProvide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activitiesEnsure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company missionEstablish standard process to ensure appropriate resolution and management of the responsible task ownerChair meetings required to drive closure of regulatory issuesManage and provide updates for regulatory metrics. Implement appropriate enhancementsRepresent regulatory processes during internal and external auditsDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targetsRecruit, select, and on-board top talentDevelop talent within team to increase performance. Actively address performance issues on teamMaintain a high level of team engagementParticipate in advocacy activities of a more advanced strategic natureEducation / Work Experience:Bachelor’s degree in engineering or other relevant field of studyMaster's Degree or equivalent preferredMinimum of 10 years’ experience requiredRAC desiredKnowledge / Competencies:Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirementsDemonstrated expertise in regulatory systems in a regulated environmentDemonstrated project management skillsDemonstrated verbal, written, and interpersonal communication skillsDemonstrated ability to work in a team environment, interact effectively with management from other functionsDemonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targetsDemonstrated ability to initiate workDemonstrated analytical abilityDemonstrated ability to make effective decisionsExperience with recruiting, people developmentInfluence 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.
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