Senior Risk Management Manager (Remote)

Job Description Summary
Summary/Purpose of Position

The Senior Manager, Risk Management will create the strategy and vision for building a PMS infrastructure to maintain compliance to applicable PMS regulations and standards. This individual and direct staff will work closely with Regulatory Affairs, Clinical Affairs and other functions to maintain PMS records for products in the BD Interventional Surgery portfolio to assure on-going compliance.
Collaborate with cross-functional team members to collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends. Oversee the development and implementation of methodologies required for ongoing post market surveillance and ties other processes (CER) led by different functions into a consistent Risk Management Lifecycle process. The incumbent will ensure compliance with applicable regulations, standards and company policies/procedures. This individual is responsible for ensuring appropriate metrics/Key Performance Indicators are defined, measured and analyzed for continuous improvement opportunities with subsequent action taken as appropriate.

Job Description

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 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

This is a remote position with some quarterly travel to the site location in Warwick RI and as needed basis.

Essential Duties and Position Responsibilities:

• Establish and maintain procedures, work instructions and templates associated with Post Market Surveillance and related Risk Management processes to maintain compliance with applicable regulations and standards.
• Create, drive and oversee processes for acquiring, leading, analyzing, interpreting and reporting Post Market Surveillance data necessary to support PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF).
• Partner with Regulatory Affairs, Clinical Affairs, product Platform teams, Field Assurance, Marketing and manufacturing facilities to proactively plan for and complete PMS reports.
• Serve as liaison between the company and various internal/external relationship sources for audits, additional information request inquiries, etc.
• Lead performance and development of staff.
• Provide staff with conflict resolution, problem solving, team building, decision making, impact management, organization awareness and relationship building assistance.
• Ensure personal and staff training is completed by established due dates. Maintain training matrices.
• Identify, run and escalate quality and personnel issues as necessary.
• Prepare and handle annual budgets in areas of responsibility.

Required Skills and Experience:

• Bachelor of Science Degree in Engineering or Technical field required; Master of Science Degree preferred.
• 8+ years of relevant experience including prior supervisory/management experience.
• Experience in the Medical Device and/or other regulated industry (Pharma, IVD).
• Strong knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001, EU MDR, etc.
• Specific strength/experience in ISO14971is a differentiating factor, as well as experience with analyzing International Medical Device Regulators Form (IMDRF) codes and their applicability to products and risk management files
• Excellent computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages.
• Ability to acquire, query and analyze data with focus on detail.
• Excellent written and verbal communication, presentation, problem solving, applied thinking and negotiation skills.
• Team leader with ability to successfully interact with representatives from a variety of fields within and external to BDI Surgery and Becton Dickinson.

Scope and Impact of Position:

• While the primary scope of the position encompasses the Post Market Surveillance process, the breadth of the related activities is across many aspects of the business including, but not limited to, product design and development, manufacturing, distribution, sales, marketing, quality engineering, field assurance, regulatory affairs, clinical affairs and customer service.
• Performance of this position has an impact on:
• Regulatory compliance and risk management consistent with marketed product requirements for globally distributed medical devices and pharmaceutical products
• Patient Safety
• Customer Satisfaction
• Product Performance
• Division and department strategic goals.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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 fulfill 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.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson, and Company are an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, color, 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, military eligibility or veteran status, or any other protected status.

PDN

Primary Work Location
USA RI - Warwick

Additional Locations

Work Shift