Senior Director, Regulatory Affairs
Senior Director, Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 223000 - 379000
1 Vacancy
Job Description
The Senior Director Regulatory Affairs is a key strategist responsible for developing regulatory strategy for the Endoscopy business unit and delivering Strykers best-in-class visualization and connectivity 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 Senior Director and team will develop and advise on product positioning product entry and exit strategies among others.
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:
- Ensure divisional achievement of quality regulatory and compliance targets
- Direct activities to ensure new product development and product sustainment meet regulatory requirements
- Develop lead and execute a regulatory strategy ensuring that it is appropriate and effective in meeting the business needs
- Responsible for the selection supervision development and objective-setting for team members
- Develop best practices to ensure compliance and drive revenue through improved customer experience
- Provide a platform for process improvement
- May serve as alternate Management Representative
- 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
- Leads advocacy activities of a more advanced and global strategic nature
Education / Work Experience:
- BS in Engineering or other relevant field of study
- Minimum of 10 years experience
- Masters 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 ability to manage complex projects
- 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
$223000 - $379000 salary plus bonus eligible generally eligible for short-term and long-term financial incentives benefits. Individual pay is based on skills experience and other relevant factors.
Travel Percentage: 20%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 contractors legal duty to furnish information.Required Experience:
Exec
Employment Type
Full-Time
