Senior Regulatory Affairs Specialist – WWISD (Project role until Oct 2021)
Switzerland/Eysins
A superb, wide-rangingRegulatory Affairscareer development role withBD, a global leader in Medical Technology.
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.
The Sr. RA specialist will represent Regulatory Affairs within WW Infusion Specialty Disposables (WWISD) platform of the Medication Delivery Solutions business unit of Becton Dickinson (BD) on new product development, product engineering, and other product development initiatives and maintenance activities.
This is a project role until end of October 2021.
JOB DESCRIPTION:
o The Regulatory Affairs Specialist will act as the Regulatory lead on cross-functional product development teams to achieve business goals.
o Provide teams with strategic and tactical guidance regarding global regulatory requirements to support product approvals/registrations.
o Independently manages multiple long-term projects with direction/support from supervisor. Interacts with supervisor as required on activities, issues, or milestones.
o Inspires effective unit dynamics and imparts a sense of commitment to unit goals.
o Develops global regulatory strategies for WWISD products.
o Prepares, submits and maintains global regulatory submissions/registrations.
o Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
SPECIFIC SKILLS & ABILITIES:
o Ability to read, analyze, and interpret regulatory literature and documents.
o Ability to format regulatory submissions that conform to prescribed style and format.
o Ability to effectively communicate information to peers and management. Ability to translate regulations and guidelines into terms that other functions can understand.
o Ability to define problems, collect data, establish facts, and draw valid conclusions, and then communicate the information both verbally and in writing to a variety of audiences.
o Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
o Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
ABOUT YOU:
o Minimum of 3-5 years professional experience preferably in life sciences or any similar industry
o Bachelor’s degree, preferably in Sciences, Engineering, or equivalent
o Be able to work in a multinational environment
o Be able to work in a very diverse Regulatory environment, with different requirements and regulations
o Be able to work in a matrix organization with different stakeholders
o Must be detail oriented
o Must be a team player
o Must be self-motivated, work independently and have the ability to work with minimal supervision
o Strong interpersonal, communication and analytical skills
o Project organizational and prioritization skills
o Ability to prioritize effectively and organize complex information
o Flexibility to multitask and shuffle between projects based on emerging priorities
o Fluent in spoken and written English
o Travel as required
It’s a superb, all-round Regulatory Affairs career development role with a world leader in medical devices.So if this describes you and your 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 Talent Pool here:emea.jobs.bd.com/#jobs-alerts-wrapper
Show More
Show Less
ApplySave Job