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Sr Manager, Corporate Post Market Surveillance

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Regulatory & Quality Assurance
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2674 Total Views

At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Job Summary

The Post Market Surveillance Senior Manager will oversee all activities related to the complaint handling process.  The Senior Manager will provide direction to individuals who receive and investigate product complaints, evaluate returned products, and perform data analysis.  They will follow established global regulations for complaint handling and prepare and assemble complaint information for regulatory inquiries and management review.  This person will provide support during inspections by regulatory bodies, ensure appropriate and timely global medical device reporting, and monitor for trends in product complaints.  This person will work with stakeholder departments such as Engineering, Operations, Service, Clinical, Medical Affairs and Regulatory on Post Market Surveillance strategy and execution.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  • Oversee Complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, etc.
  • Manage personnel and all associated activities of the Complaint Handling group including managing performance and developing talent
  • Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop, and are recognized for their contributions
  • Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities, and expedient processing and closure
  • Responsible for oversight of Adverse Event reporting program to ensure compliance
  • Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate
  • Work closely with new product introduction teams to prepare tools, processes, resources and personnel for new product launches
  • Define reports to identify delinquency or backlog in all aspects of the surveillance process
  • Identify process improvement opportunities to enhance surveillance and to increase efficiency
  • Develop and maintain data mining tools to monitor trends.  Define Control and / or Action Limits to detect emerging field issues
  • Manage preparation and reporting of quality data for purposes of post market surveillance and as the primary input into the Management Review process
  • Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities
  • Conduct and Review Health Hazard Risk assessments as assigned in conjunction with Design Assurance

Qualifications

Education  

  • Preferred B.S. in Engineering or related field

Experience 

  • Minimum 10 years related Quality experience with at least 5 years managing direct reports

Skills

  • Regulation 21 CFR Part 820, Part 803 and applicable international quality standards and regulations including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation
  • Strong analytical skills including trend and statistical analysis, interpersonal, and management skills
  • Strong leadership capabilities - able to manage a team handling high volumes of complaints, able to effectively manage cross-functional relationships and establish clear roles and responsibilities

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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