Global Post Market Surveillance Manager

We Make Life More Rewarding and Dignified

Location: Libertyville

Department: Quality

Summary:

The Post Market Surveillance Manager provides leadership within the Global Post Market Surveillance (PMS) organization.

In this role, the Manager leads, maintains and continuously improves the PMS process and procedures by identifying best practices that meet global regulatory requirements and enable timely attention to product performance feedback in an effort to continuously improve the customer experience. The Manager helps develop and implement strategies and tactics to accomplish goals. The candidate must have the ability to establish a vision and to manage a team to achieve objectives. This role oversees the Complaint Investigators for timely processing and investigation of complaints as well as data analysts to ensure proactive monitoring of product performance.

The Manager is responsible for developing relationships across the company to provide awareness of Post Market Surveillance activities and goals and to continuously collect and address customer feedback. Partnering with customer service, GMO and the commercial business units to develop customer communications is essential to address any internal or external customer issues.

The Manager will maintain proficiency on standards and regulations related to PMS.

As a people leader, competency and focus on overall team development is imperative for success in this position and to ensure the team's effectiveness.

Hollister Incorporated operates in a hybrid work environment.

Responsibilities:

• Establish, maintain and continuously improve the Global post market surveillance policies and procedures which include:
  • Global Complaint Handling process
  • Establish, maintain and continuously improve the Global post market surveillance policies and procedures which include:
    • Global Complaint Handling process
    • Post Market Surveillance, including;
      • Post Market Risk Assessment
      • Field Actions, recalls, advisories notices
      • Adverse Events & Incident Reporting
  • Acts as Person Responsible for Regulatory Compliance to ensure Vigilance reporting obligations and Post Market Surveillance activity obligations are met, post market risk determination, and field actions
  • Reviews metrics from product life-cycle processes to identify trends and potential risks
  • Supervise complaint investigators and data analyst
  • Assessment of Post Market Risk as it pertains to products in commercial distribution
  • Authoring post-market risk assessments and Health Hazard Evaluations to make risk based decisions
  • Identifying new potential risks as a result of complaint investigations and / or trends
  • Provides Inputs to pre-market risk analysis based on the information obtained from post-market data
  • Leads the Risk Management Board
  • Works with departments involved in the product life-cycle (design/development, purchasing, manufacturing, packaging, clinical affairs, distribution, regulatory) to incorporate documented risk based decisions as part of the daily post market surveillance process
  • Participates in customer visits
  • Represents Hollister in conferences
  • Interacts with regulatory agencies in response letters, questions or any queries related to customer complaints
  • Leads Adverse Event reporting and investigations
  • Support external regulatory audits
  • Provides inputs for Clinical Evaluations Reports (CER) and works with the different departments involved
  • Remain current on regulatory requirements as it pertains to post market surveillance

Requirements:

• 5-8 years overall experience
• 5+ years quality, compliance and regulatory experience in the medical device or other regulated manufacturing environment
• Bachelor's Degree scientific discipline required
  • Clinical Background (i/e: RN / BSN) is preferred
• Demonstrated experience leading teams
• Minimum 5 years' experience in complaint handling / risk assessments / field actions
• Demonstrated understanding of Medical Device requirements and international regulatory requirements, specifically related to Complaint Handling, reportable events, post market surveillance
• Experience supporting external regulatory assessments (i.e. FDA, Notified Bodies: ISO-13485, MDSAP)
• Demonstrated knowledge of ISO 14971 and its application within 21 CFR 820, EUMDR, ISO13485
• Demonstrated understanding of Medical Device requirements and international regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
• Demonstrated knowledge of ISO 14971 and its application within 21 CFR 820 & EU MDR
• Strong interpersonal skills, with the ability to work effectively in and lead teams
• Strong written and oral communication skills
• Strong organizational and analytical skills
• Ability to influence others, able to use persuasive, logical arguments based on data
• Solid understanding/working knowledge of complaint handling, product development lifecycles, risk management in a medical device environment
• Experience with medical writing
• Experience with research methods

Essential Functions of the Role:

• Must have manual dexterity (use of mouse, keyboard)
• Must be able to sit for prolonged periods of time (6-8 hours per day)
• Must be able to stand for significant periods of time (4-6 hours per day)
• Ability to travel (10% Global)
• Speak/write in English

#LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, generous paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. Find out more at www.Hollister.com.

Hollister is an EO employer - M/F/Veteran/Disability

Job Req ID: 32546