BD (Becton, Dickinson and Company) Regulatory Affairs Project Manager in Warwick, Rhode Island

BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.

Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.

This position will be responsible for project management of programs with regulatory consequences and significant cross functional support for the Surgery Business Unit. The initial focus will be overall execution and implementation of the European Medical Device Regulation (EU MDR) on a business unit level. The Project Manager will provide direction and leadership to a cross-functional team including subject matter experts (SME) and requires the ability to drive strategic initiatives while also managing tactical activities and communicating effectively with a large group of stakeholders. The Project Manager is responsible for ensuring team commitments (scope, schedule and budget) are met and for communicating program status to senior leadership on a regular basis.

  • Lead the coordination and management of cross-functional team comprising of quality, regulatory, manufacturing, and engineering to develop, communicate, and measure progress against goals and metrics for program success.

  • Lead efforts to determine and develop strategic approaches for entire program.

  • Track and manage project deliverables and cost against budget; report and advise on recovery plans necessary to achieve budget targets.

  • Develop tracking spreadsheets, assemble presentations, dashboards and other project tools as necessary to drive the overall program.

  • Prepare and provide status update, communications, and other presentations across the business unit at all levels.

  • Special projects as assigned.

  • BS/BA degree or equivalent degree in Business Management, Engineering, or other related field of study.

  • Minimum 6-8 years of experience required in QA and/or RA, or a function familiar with technical files and medical device product development process.

  • Minimum of 5 years of QA/RA, plant manufacturing or engineering experience, which includes 5 years of demonstrated process improvement and project management success.

  • Experience driving initiative and change management across a Business Unit.

  • Demonstrated ability to work successfully in complex business and project areas, leveraging interpersonal skills and technical skills to optimize results.

  • Excellent verbal, written communication and presentation skills.

  • Experience delivering presentations and influencing stakeholders at all levels in an organization.

  • Broad business knowledge and ability to link customer needs with business processes.

  • Strong analytical problem-solving skills.

  • Ability to support multiple projects and balance priorities.

  • Strong coaching, facilitation and organizational skills.

  • Ability to travel approximately 10% of time.

  • Master’s degree preferred.

BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.

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Industry Standard/Category: Medical Device / Project Management

ID: 2018-11468

Career Level: experienced

Division Name: BD Interventional Surgery

Relocation: No

External Company Name: C.R. Bard, Inc.

External Company URL: www.crbard.com

Street: 100 Crossings Boulevard

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.