Principal Regulatory Affairs Specialist

Work Flexibility: Remote or Hybrid or Onsite

Stryker is seeking a Principal Regulatory Affairs Specialist to support our Instruments division. This is a Hybrid or Remote role with in office expectations, to be based in Portage, Michigan. Candidates that reside within the Central US or are willing to relocate will be given preference.

 

This role is ideal for a regulatory expert with a strong track record in global submissions and cross-functional collaboration.

 

What you will do

• Lead global regulatory strategies for new product development and market expansion

• Prepare and manage submissions to FDA, Notified Bodies, and other global agencies

• Advise cross-functional teams on regulatory pathways, risks, and compliance requirements

• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)

• Monitor and interpret evolving regulations to ensure ongoing product compliance

• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations

• Represent the company in high-level negotiations with regulatory bodies

• Guide labeling, claims, and clinical strategies to align with regulatory expectations

• Develop and implement regulatory SOPs and training programs

What you need

Required

• Bachelor’s degree in Engineering, Science, or related field

• 9+ years experience in an FDA regulated industry

• 7+ years experience in medical device regulatory affairs

• Proven experience with FDA submissions and global regulatory interactions

• Deep knowledge of 21 CFR, MDD/MDR, and post-market requirements

Preferred

• MS in Regulatory Science and/or RAC

• Experience with Class I/II devices; PPE and M&A exposure

• Strong understanding of eCTD and regulatory documentation systems

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$115,600.00 - $245,800.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. 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 contractor’s legal duty to furnish information.