Junior Post Market Quality Specialist
3 days ago
**Job Description Summary**:
**Be part of something bigger**
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 75,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
**What we can offer you**
The BD Way of working
This role is offering 14 months contract, Monday to Friday, working 35 hours per week and the option to work fully remotely.
We are also offering a competitive salary and substantial benefits package (including AXA private healthcare)
**About the role & the site**
BD Winnersh is the UK headquarters and the office is located in the modern Winnersh Triangle Business Park, Wokingham, Berkshire with approx. 690 employees. This role is part of the MMS - Medication Management Solutions Group
This role provides support to the Regulatory Compliance team. You will be responsible for determining the reportability of complaints, coordinating regulatory reporting activities and ensuring reporting timeframes are being met. In doing so, they will collaborate with the Post Market Quality Supervisor to prepare accurate and complete MDR, MDPR and Manufacturer’s Incident Reports MIR. You will act as liaison with competent authorities for vigilance matters and ensure complete, accurate and timely reporting of MIR/MDR/MDPR as required by regulatory agencies.
**Key responsibilities will include**:
- On top of the above, you will: Communicate directly with BD International Affiliates and customers to gather additional information needed to complete investigations and reporting requirements.
- Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
- Provide accurate sales data and complaint trend reporting to support requests by regulatory bodies.
- Maintain awareness of new and developing trends and requirements related to the evaluation and reporting of medical device-related incidents.
- Escalate high-priority issues as well as identified business risks to the appropriate management level.
- Collaborate with investigation engineers to identify, facilitate and prioritise complaints to meet regulatory agencies' deadlines.
**About You**
- Some experience in Adverse Event handling and vigilance reporting in accordance with applicable MEDDEV guidance, and European/Emerging Market/MDR regulatory requirements for post-market activities
- Knowledge of the European Medical Device Directive and the Medical Device Regulations
- Some knowledge of FDA, and Canadian Regulations.
- Strong sense of customer focus
- Experience in the healthcare industry or medical device manufacturing
- Conscientious, detail-orientated approach to work
**Why join us?**
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfil their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, colour, 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, or any other protected status.
**Primary Work Location**: GBR Winnersh - Eskdale Road
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