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We are seeking a **Senior Regulatory Specialist** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid two to three days per week in Mahwah, NJ or Weston, FL.

What you will do

As the **Senior Regulatory Affairs Specialist** , you will support Stryker’s Mako and Enabling Technology portfolio new product development for both US and OUS Global Regulatory release. Mako and Enabling Technologies portfolio covers three technology pillars, robotics, navigation and imaging which includes capital equipment, navigation, robotics, software devices, and/or associated accessories and instruments and provides unique opportunities to collaborate across various Stryker divisions. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing material, and evaluate proposed device changes.

+ Assess regulatory landscape to create the development of global regulatory strategies

+ Identify requirements and anticipate regulatory obstacles for market access distribution and update regulatory strategy based on changes.

+ Determine requirements and options for regulatory submission, approval pathways, and compliance activities.

+ Provide regulatory information and guidance during product development, planning, and review proposed product claims/labeling throughout the product lifecycle.

+ Work with regulatory authorities and track review progress through clear communication.

+ Identify the need for new regulatory procedures, SOPs, and helps train stakeholders to ensure organization-wide compliance.

+ Prepare and submit electronic submissions, ensuring consistency with regulatory requirements.

What you need

Required

+ Bachelors Degree in Engineering, Science, or related

+ 3+ years of experience in an FDA regulated industry

+ 2+ years of experience in medical device regulatory affairs

+ Thorough understanding of FDA, Europe, and international medical device regulations

+ Experience drafting regulatory submissions for product approval

Preferred

+ RAC certification or Advanced Degree (Masters in Regulatory Affairs)

+ Previous experience with Class II/III medical devices

+ Previous experience drafting 510(k)s

+ Experience interacting with regulatory agencies

$87,600.00 - $148,400.00 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.