Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Senior Manager, Regulatory Affairs Projects - BDI

Expired Job

BD (Becton, Dickinson And Company) Franklin Lakes , NJ 07417

Posted 4 months ago

Job Description: SummaryThe Regulatory Project Manager is responsible for the leadership and execution of moderate to high complexity regulatory projects with considerable resources within the BD Interventional Segment.

Job Description

Determine and discern detailed requirements on larger scale regulatory projects and Cost Synergy Program to establish the project deliverables, and manages changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes.

Develop project plan and timeline.

Establish and maintain team members and project stakeholder relationships, expectations, and communications.

Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify risks, perform required corrective actions, and communicate to all stakeholders up, down and sideways.

Execute and lead the execution of tasks as defined in the project management plan in order to achieve the project goals, and actively manages project risk.

Serve as a project management subject matter expert, keep Regulatory Affairs leadership abreast of project schedules and potential areas of conflict/concerns or delays.

Interface with senior management and support decision-making. Monitor timelines and developing strategies to stay on schedule and navigating through the internal regulatory and global program team governance for projects across BDI business units.


B.S. degree or higher in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering and regulatory affairs.


Project Management Certification preferred RAC is a plus


  • Minimum of 10 years of experience working in medical device industry or equivalent

  • 4-7 years of regulatory affairs experience

  • Knowledge of international medical device registration requirements, e.g. China, Japan.

  • Well-versed in program and project management tools and practices

  • Knowledge of quality systems and EU regulatory requirements


  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.

  • Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities.

  • Project Management skills

  • Attention to details and organized.


  • FDA 21 CFR Part 820, ISO 13485

This position is through 9/30/2020. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BDX.


Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work Shift

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Regulatory Affairs Specialist

BD (Becton, Dickinson And Company)

Posted 7 days ago

VIEW JOBS 12/3/2018 12:00:00 AM 2019-03-03T00:00 Job Description SummaryThis position will be responsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions for medical devices. The incumbent will perform essential duties and responsibilities with some supervision . Job Description * Represent the Regulatory Affairs function at the global cross functional business or product platform level * Analyze and interpret current or proposed domestic and international regulations for impact to BD products and processes to help ensure continuous compliance. * Develop and execute global regulatory strategies by collaborating closely with cross-functional product development teams and regulatory associates around the world. * Assess the impact of device modifications and develop robust non-filing justifications for US/EU regulated products Coordinate and prepare premarket applications to the US FDA such as pre-submission meetings, 510(k)s... * Coordinate and prepare submissions to European Notified Bodies for timely approval of new products and product changes. * Provide support to regional regulatory associates for timely approval of BD products worldwide. * Review and approve product labeling for compliance to global regulatory requirements. Education: B.S. degree or higher in a technical discipline, preferably in engineering, bio-engineering, biology, or chemistry. Experience: * At least 3 years of experience with medical device regulations is required. * Understanding of regulatory frameworks and the ability to interpret and apply new or emerging regulations. Skills: * Strong organizational and written/verbal communication * Attention to detail * Demonstrated problem solving abilities * Self-motivated with the ability to effectively manage and prioritize multiple complex tasks #LI-KL1 Primary Work LocationUSA NJ - Franklin Lakes Additional Locations Work Shift BD (Becton, Dickinson And Company) Franklin Lakes NJ

Senior Manager, Regulatory Affairs Projects - BDI

Expired Job

BD (Becton, Dickinson And Company)