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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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.