The new Quality System Speciliast colleague will be part of the Global Quality System organization and their main responsibility is focused on global post market follow up activities. In this role, the colleague will have daily responsibilities for: managing and assuring PMPF deliverables are completed on a timely manner (e.g. scientific literature review, post market clinical studies, marketing evaluations, clinical and published experience gained, as well as assessment of product benefit risk and overall report conclusion). As part of the global post market surveillance reporting team, the candidate will be planning, scheduling, analyzing resource allocation and coordinating cross functional meetings and serving as liaison between PMPF and PSUR Team members while resolving any quality issue that may arise. This includes regular interactions with area subject mater experts to ensure data is collected, documented and analyzed in a timely and accurate manner.
Please note that this is a fixed-term position for 12 months.
How You’ll make an impact:
- Harmonization of PMPF process and assures tasks are carried out by overseeing the generation and
- scheduling of Post Market Performance Follow up reports
- Coordinates and executes PMPF activities among cross-functional teams (R&D, Clinical Affairs, Marketing,
- RA/QA) in order to obtain deliverables
- Guarantee all PMPF deliverables are prioritized, executed and aligned according to the PSUR Report
- Responsible for coordination of PMPF Plans revisions and PER, as needed.
- Evaluates the needs of team members and escalates high risk issues to management representative as needed.
- Highly organized and manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solving
- Facilitate cross functional requirements from global business partners
- Coordinate post market performance follow up report activities to ensure completion of periodic reports
- Work with business partners to identify and escalate product performance issues and recommend actions as appropriate
- Ensure reports comply with internal QMS and ISO 13485 and EU IVDR requirements
- Assure alignment with PMPF and PSUR Reporting processes are met
What You'll bring:
- Education: BS in science related field (Biology, Chemistry or Pharmaceutical) or ideally 5 years’ experience working in a
- Quality / Regulatory / Project Management field
- Work Experience: minimum of 3 years managing projects or in administrator role, familiar with IVDR post
- Marketing regulation is preferred
- Advance English level: Able to communicate effectively in English verbally and written as well
- Ability to prioritize and meet deadlines
- Strong analytical and writing skills
- Proficient use of Microsoft applications: Word, Excel, Power Point, OneDrive, SharePoint, Teams
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: 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:
- Life and accident insurance,
- Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
- Competitive salary and cafeteria
- 100% commuting allowance for non Budapest residents
- Annual bonus
- Annual salary review
- Marriage and childbirth allowance
- School start allowance
- All You Can Move contract possibility/gym facility discount
- Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)
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