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Stryker
Portage, Michigan; Michigan, Portage 1941 Stryker Way
Source: Stryker careers · View original posting
From Stryker's posting. “We” and “our” refer to the employer.
Work Flexibility: Hybrid
Stryker is seeking a Manager, Regulatory Affairs to support our Surgical Technologies business. This hybrid role is based in Portage, Michigan , with an expectation of onsite collaboration a minimum of three days per week.
As the Manager, Regulatory Affairs , you will guide global regulatory strategy across the product lifecycle. This position serves as a key partner to Product Development, Clinical, Quality, Manufacturing, Marketing, and Commercial teams, ensuring regulatory requirements are integrated into business decisions, market access strategies, and product development plans.
In addition to providing technical and strategic regulatory expertise, this role leads regulatory processes, regulatory authority interactions, and team development activities that support global business objectives.
This role is ideal for an experienced regulatory affairs leader who enjoys balancing strategic planning, regulatory execution, cross-functional leadership, and team development within a complex global regulatory environment.
Required
Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific discipline.
Minimum 6 years of experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industry.
Experience preparing, reviewing, or overseeing regulatory submissions and regulatory authority interactions.
People management experience or demonstrated experience leading critical cross-functional programs or projects.
Experience with FDA, European Union, and international regulatory requirements including Quality System & ISO standard requirements.
Fluency in English.
Preferred
Master’s degree in Engineering, Life Sciences, Regulatory Affairs, Business, or a related field.
Regulatory Affairs Certification (RAC).
Experience managing teams, performance objectives, budgets, and organizational development initiatives.
Experience developing and executing regulatory strategies across the product lifecycle.
USN : $126,500 - $210,700 USD Annual
Travel Percentage: 20%
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.
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.
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