Hollister Incorporated · 11 hours ago
Lead Post Market Surveillance Specialist
Libertyville, IL
Part-time
Hybrid
Senior Level, Lead/Staff
$91K/yr - $131K/yr
8+ years expHollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The Lead Post Market Surveillance Specialist ensures the safety and regulatory compliance of products after market release, leading risk assessments and collaborating with cross-functional teams to address issues and improve processes.
Health CareManufacturing
Responsibilities
Lead and coordinate post market risk assessments to evaluate the impact of post-market events on patient safety and product effectiveness
Prepare comprehensive reports summarizing clinical risks, trends, and potential implications for product safety
Leads assessment of PMRAs and able to process, evaluate, and recommend PMRAs for field actions according to regulations and procedures, as applicable
Collaborate with medical professionals to assess the clinical significance of adverse events and identify potential risks
Leads Field Actions according to procedure and regulations. Which includes Field Action plan and log, developing customer communication, managing consignee list and tracking response forms, and notification to Regulatory Authorities according to regulations as applicable
Monitor and analyze post-market data, including customer complaints, adverse events, proactive PMS surveys/product evaluations and product performance metrics
Lead and oversee complex complaint investigations, including those related to serious incidents and potential recalls
Assist with the review and processing of complaints in a timely manner according to regulations
Help provide high level customer support and serves as a liaison and subject matter expert between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints
Ensure compliance with relevant regulatory requirements and standards related to post-market surveillance
Stay abreast of regulatory changes and updates, incorporating them into the post-market surveillance process
Proactively prepares for audit readiness. Provides support during internal and external audits. Provide support for requests that come during audit and represents complaint team in front of the auditors
Acts as the SME for adverse event/vigilance reporting
Responsible for adverse event/vigilance assessment, decision trees and reporting to the regulatory authorities as well as training other team members of these job duties
Acts as adverse event/vigilance pre submission reviewer
Authors post-market surveillance reports as required [PMS plans and Reports, Periodic Safety Update Reports (PSUR)]
Collaborate with Global Clinical Affairs to develop Post Market Clinical Follow-up (PMCF) plans, studies and reports, as applicable
Communicate findings and recommendations to internal stakeholders, including management
Collaborate with other departments such as Clinical Affairs, R&D, Quality Assurance, and Regulatory Affairs to address identified issues and potential clinical risks. Encourage implementation of corrective and preventive actions
Collaborate with Global Market Access, Global Marketing Organization, Global Clinical Affairs to develop proactive post market surveillance surveys and evaluations
Participate in cross-functional teams to provide post-market surveillance expertise in product development and improvement efforts
Identify and analyze trends in post-market data to proactively address potential issues
Contribute to risk management activities by assessing and mitigating risks associated with post-market surveillance findings
Other duties as needed or required
Qualification
Required
8-12 years of overall experience
Minimum 8 years PMS experience including progressive responsibilities including training, problem solving, report generation, and complaint management
Bachelor's degree in medical field and 8+ years of industry experience
5 years Clinical Experience
Knowledge of ISO 13485, 21CFR part 820, EU MDR, MEDDEV, Health Canada, and other international regulations for the medical device industry
Excellent communication skills – verbal and written
Experience with Microsoft Office suite
Goal and result oriented with a proven record of success
Demonstrated problem solving skills and implementation of new processes
Strong organizational and time management skills
Ability to work under pressure and exhibit multi-tasking capabilities
Self-motivated and self-directed
Positive attitude
Strong interpersonal and decision-making skills
Strong analytical and problem-solving skills
Strong understanding of global regulatory requirements for PMS
Understanding of medical terminology
Ability to interpret and communicate complex clinical information to diverse stakeholders
Manual dexterity (use of mouse, keyboard) – to type and enter data into a computer
Ability to sit for prolonged periods of time (6-8 hours per day)
Ability to stand for significant periods of time (3-4 hours per day)
Ability to handle multiple prolonged telephone conversations
Ability to travel and perform customer visits
Preferred
ASQ CQE or CQA preferred but not required
Benefits
Health and life insurance
Wellness programs and incentives
Generous retirement savings
Medical
Prescription
Dental
Vision
Spending/savings accounts
Disability
Company paid (parental and caregiver) leaves
Statutory leaves/disability programs
Accident
Life
Wellbeing
Education assistance
Adoption assistance
Voluntary benefit programs
401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions
11 paid holidays
Paid vacation based on length of service and exempt/non-exempt status
Sick days based on statutory requirements and/or exempt/non-exempt status
Education assistance and adoption assistance benefit programs
Company
Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
1001-5000 employees
H1B Sponsorship
Hollister Incorporated 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 (1)
2023 (1)
2022 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Abinash Nayak
President and COO
scott holloway
Executive Vice President and Chief Commercial Officer
Recent News
2026-01-20
Digital Music News
2026-01-06
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