Post Market Surveillance Specialist - Remote

Stryker • Mahwah, NJ

3d • Remote

About The Position

Post Market Specialist - Remote Drive patient safety and product excellence. In this role, you’ll ensure that Stryker’s medical devices continue to meet the highest standards after they reach the market. Your work will influence global compliance, improve product performance, and help deliver better outcomes for patients worldwide. If you’re passionate about data, regulations, and making a real impact, this is your opportunity. Work Flexibility: Remote: This is a remote position. While candidates may be located in various locations, preference will be given to those based within the U.S. East Coast time zone to support collaboration and alignment with business needs.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• 0+ years of experience (entry-level candidates welcome).

Nice To Haves

• Master’s degree in Regulatory Science or related discipline.
• Familiarity with complaint handling systems and adverse event reporting.
• Experience with statistical analysis tools for data trending.
• Knowledge of international regulatory frameworks (Health Canada, MDD, etc.).
• Ability to work with regulatory requirements such as EU MDR (2017/745), ISO 13485, and FDA regulations.

Responsibilities

• Develop and maintain Post Market Surveillance (PMS) documentation, including PMS Plans, Reports, and Periodic Safety Update Reports, in compliance with international regulations.
• Analyze complaint and quality performance data using systems such as TrackWise to identify trends and support proactive risk management.
• Perform statistical trending and contribute to the enhancement of PMS methodologies.
• Conduct proactive PMS activities, including web screening, MAUDE searches, and customer surveys, to identify emerging issues.
• Collaborate with Clinical, Marketing, and R&D teams to gather inputs and ensure timely completion of PMS deliverables.
• Submit PMS-related information to regulatory authorities within required timelines.
• Support audits by presenting PMS processes and documentation accurately and professionally.
• Identify and implement improvements in PMS processes, SOPs, and work instructions to enhance compliance and efficiency.

Benefits

• bonus eligible
• benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees