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:
BS in Engineering or other relevant field of study
Minimum of 10 years’ experience
Master's Degree or equivalent preferred
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
Compensation:
$149,300- $329,000 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: 30%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.