Job Description Summary

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 position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through May 31, 2024.

Regulatory Affairs (RA) Manager is responsible for the preparation and documentation of regulatory submissions to government agencies. This includes activities such as preparation and/or oversight of clearance/approval/registration/licensure documentation for regulatory submissions to government agencies (worldwide), performing tasks associated with obtaining and maintaining product clearances licenses and registrations, and leading pre-market and post-market activities. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by delegating work and resolving complex problems. The RA Manager works on problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Manage, plan, and coordinate work of Regulatory Affairs department.

• Implement company and departmental goals, objectives, and enforce requirements of quality work. Ensure RA department processes and procedures related to regulatory responsibilities are compliant, current and efficient.

• Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document, and implement a regulatory submission plan around product development/line extension goals.

• Prepare U.S. FDA 510(k), IDE, PMA, submissions as required. Prepare and update Europeans and international product dossiers/registrations as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, and scientifically based.

• Review product labeling, advertising and promotional materials.

• Develop, monitor, and report to senior management key performance indicators.

• Maintain establishment registrations and device listings as required.

• Ensure adequate documentation of BPV’s compliance to FDA, European, and international regulations and standards. Ensure continuous update and maintenance of the Regulatory Affairs files.

• Provide Regulatory support to regulatory inspections, such as ISO and FDA audits.

• Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance, and BPV’s notified body.

• Understands BD culture and values and reflects them in his/ her own behavior.

Required Qualifications:

• Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.

• Demonstrated self-starter, and highly motivated.

• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.

• Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.

• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.

• Demonstrated ability to effectively formulate and drive change.

• Experienced in continuous improvement projects, project management, product development processes, and design control.

• Ability to be effective in complex projects with ambiguity and/or rapid change.

• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.

• Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint).

• Orientation for detail work product, with emphasis on accuracy and completeness.

• Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc.

• Knowledge of medical device testing methods and statistics, as applicable.

Preferred Qualifications:

• RAC Certification

• EU MDR Experience

• FDA Class III Experience

Education and/or Experience:

• Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering, or medical-related field.

• Minimum of five years regulatory affairs or related experience in medical device industry.

• Minimum of one year managerial experience.

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 is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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.

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