Associate Manager, Regulatory Affairs
Associate Manager, Regulatory Affairs
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Job Description
Stryker is hiring an Associate Manager Regulatory Affairs preferrable in Portage MI to join our Craniomaxillofacial (CMF) Business! In this role you will lead and manage a team of regulatory professionals to ensure compliance with applicable regulatory requirements at the local state and federal levels. You will drive the implementation of these regulations to ensure ongoing compliance.
Work Flexibility: Remote hybrid or onsite. It is strongly preferred that the candidate be based within a commuting distance of Portage MI.
Travel: The selected candidate should be comfortable traveling once a quarter.
Key areas of responsibility
Lead teams to support regulatory processes for market access of products
Manage budget if appropriate
May lead the development of new systems and procedures
Plans conduct and supervise assignments
Reviews progress and evaluate results
Support continuous improvement activities
Define targets KPIs performance objectives etc. for individuals within functional role and manage direct reports to meet or exceed these targets
Recruit and onboard top talent develop team capabilities proactively manage performance and foster high team engagement
Participates in advocacy activities of a technical audit/nature
What you need:
Required:
Bachelors degree required. Preferred degree in a science engineering or related field.
6 years of regulatory experience.
Preferred:
Masters Degree or RAC preferred
Previous supervisory experience preferred
Experience with Class III Premarket Approval devices is highly desirable
Familiarity with European medical device regulations
Regulatory Affairs experience within Medical Device preferred
Demonstrated knowledge and application of regulatory requirements including ISO FDA and international requirements
Demonstrate technical knowledge of medical devices tissues and/or drug product lines
Strong communication team building and leadership skills
Proven ability to lead crossfunctional teams manage multiple projects and drive process improvements
Experience mentoring interns interviewing candidates recruiting and coaching and developing team members preferred
Understanding of scientific and health concepts
$100500 $210000 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on 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:
Manager
Employment Type
Full-Time
