Stryker · 2 days ago
Post Market Surveillance Specialist - Remote
United States
Full-time
Remote
New Grad, Entry Level
$62K/yr - $114K/yr
0+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. They are seeking a Post Market Surveillance Specialist who will ensure that medical devices meet high standards post-market, analyze data for compliance, and collaborate with various teams to enhance product performance.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field
0+ years of experience (entry-level candidates welcome)
Preferred
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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase