Post Market Surveillance Manager - Operations & Data Analytics
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Before you apply
LocationBudapest, UNAVAILABLE, HU
Work modehybrid
Typefull-time
SenioritySenior
Experience5+ yrs
DepartmentManagement
Company size10,000+ people
PostedOct 18, 2024 · 2y ago
Verified live3d ago
May no longer be actively hiring
Posted by the company on Oct 18, 2024100% of this company's open roles have been listed for 90+ days
At a glanceSummarised by Seekless from the posting.
Bachelor's degree in a relevant discipline (Engineering, Life Sciences, Data Science or similar)
At least 5 years of experience leading a complaint trending, post-market surveillance or analytics team, including hiring, developing and managing analysts
Experience working in a regulated quality system — preferably medical device or in vitro diagnostics — including validation of software used in quality processes
Demonstrated experience in data analytics, process automation and the responsible deployment of AI in a business setting
Proven ability to lead cross-functionally and build strong relationships across a global organization, with strong analytical, organizational, communication and presentation skills
Fluent written and spoken English
Advanced degree a plus
Working understanding of FDA, EU IVDR, ISO 13485, ISO 14971 and post-market surveillance requirements
Experience with CRM and complaint management systems, Snowflake and Power BI
Internal and external audit experience
Skills
Snowflake
Power BI
Benefits
Life insurance
Accident insurance
Private health care
Commuting allowance
Annual bonus
Annual salary review
Marriage allowance
Childbirth allowance
School start allowance
Loyalty award
Employee referral program
Gym membership
Hybrid working
Overview
As Post Market Surveillance (PMS) Operations Manager you’ll manage the team that defines how Bio-Rad turns post-market data into insight. You’ll own the PMS analytics and systems roadmap, deciding where to implement automation, predictive analytics and AI, and you’ll be accountable for the dashboards, metrics and complaint trending our PMS Quality, Regulatory and commercial stakeholders depend on. Day to day you’ll balance management and substance: reviewing trending output and emerging signals with your analysts, working with IT and Digital on the systems and data architecture behind complaint management, aligning with global process owners, and presenting to senior leadership. You’ll also oversee operations such as coordination of a global training program and the publishing of documentation. You’ll lead a small team based in EMEA supporting a global organization, and report to the Senior Director, Post Market Surveillance.
How You’ll Make an Impact
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Own global complaint trending and signal detection.Lead trending, signal detection and post-market data analytics across Bio-Rad’s product portfolio, driving proactive safety and performance monitoring at scale.
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Be the business owner for PMS systems and data.Hold accountability for complaint management systems, data governance and data architecture from a quality and regulatory standpoint, partnering with IT and Digital on delivery.
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Set the analytics roadmap.Define and execute a multi-year plan for PMS analytics — identifying where automation, predictive analytics and AI create real value, and ensuring each is deployed with the controls a regulated environment demands.
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Make post-market data decision-ready for leadership.Design and deploy executive and operational dashboards that translate complex post-market data into insight aligned with FDA, EU IVDR and ISO 13485 expectations.
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Build and grow the team.Lead, mentor and develop an EMEA-based analytics team, and oversee the global training program for Global Customer Operations and channel partners together with the field bulletins it supports.
What You Bring
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Bachelor’s degree in a relevant discipline (Engineering, Life Sciences, Data Science or similar); advanced degree a plus.
•
At least 5 years of experience leading a complaint trending, post-market surveillance or analytics team, including hiring, developing and managing analysts.
•
Experience working in a regulated quality system — preferably medical device or in vitro diagnostics — including validation of software used in quality processes.
•
Demonstrated experience in data analytics, process automation and the responsible deployment of AI in a business setting.
•
Proven ability to lead cross-functionally and build strong relationships across a global organization, with strong analytical, organizational, communication and presentation skills.
•
Fluent written and spoken English, strong stakeholder communication skills, and the flexibility to occasionally adjust working hours to collaborate across global time zones.
•
Preferred: working understanding of FDA, EU IVDR, ISO 13485, ISO 14971 and post-market surveillance requirements; experience with CRM and complaint management systems, Snowflake and Power BI; internal and external audit experience.
About the company
Who we are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
Benefits
Benefits: Bio-Rad’s biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer a variety of options, including:
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Life and accident insurance,
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Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
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Competitive salary and cafeteria
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100% commuting allowance for non-Budapest residents, monthly BKK pass
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Annual bonus
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Annual salary review
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Marriage and childbirth allowance
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School start allowance
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Loyalty award
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Employee Referral Program with remarkable referral bonus
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All You Can Move contract possibility/gym facility usage for free of charge
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Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)