Stryker Group
Senior Director, Regulatory Affairs
Stryker Group, California, Missouri, United States, 65018
The
Senior 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 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.
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
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 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
$171,500 - $379,000 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.
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Senior 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 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.
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
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 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
$171,500 - $379,000 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.
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