Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Responsibilities
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Job Summary**
The Post-Market Quality Administrator supports the Becton Dickinson ) Post-Market Quality team by managing and processing post-market quality data, ensuring compliance with regulatory requirements and internal procedures for medical devices.
Job Responsibilities**
* Process and manage post-market quality records, including Situation Analysis, Health Risk Assessments and Field Action Committees, within established timelines.
* Accurately record and maintain detailed documentation of all post-market quality activities in relevant databases and systems.
* Support the regional PMQ teams in executing field actions by gathering necessary information, retrieving relevant records, and coordinating with other departments as required.
* Generate routine reports on post-market quality data, trends, and key performance indicators.
* Maintain and update post-market quality procedures and work instructions to ensure ongoing compliance.
* Assist in preparing for internal and external audits by compiling documentation and providing administrative support.
* Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and customer service, to address quality issues.
* Participate in continuous improvement initiatives related to post-market surveillance processes.
* Adhere to all company policies, procedures, and relevant medical device regulations (e.g., MDR, FDA QSR).
Job Qualifications**
* Minimum of 2 years of experience in a quality assurance or administrative role within the medical device or pharmaceutical industry.
* Strong understanding of quality management systems (e.g., ISO 13485) and medical device regulations.
* Proficient in using quality management software and enterprise resource planning (ERP) systems.
* Excellent data entry skills and attention to detail.
* Strong organizational and time management abilities, with the capacity to manage multiple tasks concurrently.
* Effective written and verbal communication skills.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
* Ability to work independently and as part of a team.
* A Levels or equivalent qualification in a science-related field or relevant experience.
* Bachelor's degree in a scientific or engineering discipline preferred.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
POL Wroclaw - LegnickaAdditional Locations
Work Shift
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
zł79,800.00 - zł121,725.00 PLN AnnualSuccess Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
