BD (Becton, Dickinson and Company) Senior Manager Compliance in Temse, Belgium
Job Description Summary
A great opportunity to join BD's Quality & Regulatory Compliance team to support their Medication Management Solutions business
Job Location: Any of BD offices in Europe
This role provides post-market Compliance support to the Medication Management Solutions (MMS) business. The incumbent will be responsible for overseeing and participating in day-to-day compliance activities relating to product risk assessment, notification and evaluation of incidents, competent authority inquiries and follow up, field actions and Quality Management System process integration and alignment. The individual will take the lead role in supporting BD to proactively address MMS compliance needs for products and processes in Europe and other geographies outside the U.S. (OUS).
MAIN ROLE AND RESPONSIBILITIES
This provides a general focus for the requirements of the role but is not exhaustive.
Lead the resolution of outstanding and current MMS OUS compliance issues
Support integration of new business acquisition processes and procedures into existing BD model; identify and implement optimization opportunities
Manage relationships with competent authorities, ensuring deliverables and timelines are met
Assess reported events to determine regulatory reportability; prepare vigilance/regulatory reports as well as communications to Competent Authorities, as required
Work with other Platform leaders on identified projects and support key Platform goals and objectives
Participate in the preparation and execution of FSCA/FSN for impacted products
Assist with the preparation, tracking, monitoring and communication of monthly metrics and other data
Escalate high priority issues as well as identified business risks to the appropriate management level
Support and participate in audits performed by internal and external (e.g. Notified Body) representatives
Represent MMS OUS Quality at scheduled risk management and Platform meetings
Maintain awareness of new and developing trends and requirements related to medical devices, including the evaluation and reporting of medical device related incidents
Carry out other ad hoc duties as assigned by the Senior Director
Finally, willing to travel regularly, up to 25% of the time.
Degree level or equivalent qualification in a relevant subject area.
A minimum of 10 years’ experience in medical device QA and/or RA, preferably in compliance-based roles.
In-depth knowledge of European Medical Device Directive and the new Medical Device Regulation
Experience in Adverse Event handling and vigilance reporting in accordance with applicable MEDDEV guidance and European/Emerging Market/international geography regulatory requirements for post market activities
Demonstrated experience dealing with competent authorities and other regulatory bodies
Strong understanding of FSCA and FSN reporting in accordance with applicable MEDDEV guidance and European/Emerging Market/international geography regulatory requirements for post market activities
Project management and/or process change (process improvement) experience with the ability to simultaneously work on multiple projects/activities of various disciplines
Ability to critically think, solve problems (i.e. solution seeker) and meet deadlines.
Experience in healthcare industry or medical device manufacturing
Conscientious, detail-orientated approach to work
Excellent written and verbal communication skills; ability to effectively present information to management, groups and/or customers
High levels of planning and organisational skills
Professional self-starter; able to work alone and as part of a team
Interpersonal skills with ability to influence others
Ability to deal with sensitive information in an appropriate and confidential manner
Computer literacy with Microsoft Office packages with a strong working knowledge of Excel and PowerPoint.
If this describes you and your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Primary Work Location
GBR Winnersh - Eskdale Road
BEL Temse - Laagstraat, IRL - BD Research Centre Ireland
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.