Job Description

Job Description Summary

The Sr. Manager, Regulatory Affairs will lead, plan, coordinate, conduct and report on regulatory registration programs. This includes activities such as registration strategy for management of clearance/approval/registration/licensure documentation for submissions to regulatory agencies worldwide. This individual will execute department and cross functional projects, identify regulatory activities for project schedules, serve as a core team member/extended core team leader, and recommend appropriate actions on regulatory issues. In addition, provide assurance that processes and procedures related to regulatory responsibility are compliant, current and efficient.

The Sr. Manager, Regulatory Affairs solves problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors and interpretation. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

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.

DUTIES AND RESPONSIBILITIES:

* Represents the function on designated core teams, and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including advertising and promotional materials) in the context of submissions or registrations, and serve as the regulatory professional on the projects.
* Develops and executes regulatory strategies for a range of sophisticated new products with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.).
* Advocates efficient approaches to product clearance/approval, interpreting and providing regulatory requirements.
* Coordinates and prepares regulatory submissions, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications.
* Lead regulatory affairs team members responsible for pre-market and post-market submissions
* Develops, monitors, and reports to senior management key performance indicators. Mentors regulatory associates and develop for career advancement.
* Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives (e.g., compliance with new registration requirements, or professional development with minimum supervision).

MINIMUM QUALIFICATIONS:

* Experience authoring FDA 510(k) submission a must. PMA a plus
* Solid understanding of U.S. and EU Medical Device/IVD regulatory requirements
* Proven self-starter and highly motivated, energetic and enthusiastic
* Driven leadership with an emphasis on talent development
* Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
* Proven ability to juggle and prioritize tasks and schedule work to meet business needs.
* Organizational, planning, and program management skills,
* Proven ability to effectively formulate and motivate change
* Experienced in continuous improvement projects, project management, and product development processes.
* Ability to be effective in sophisticated projects with ambiguity and/or rapid change
* Excellent written and verbal communication skills and negotiate with Regulators.
* Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc.
* Digital literacy (Document management system like SAP, PC, Microsoft Word/Excel/PowerPoint)
* Willingness to travel up to 20% of the time (domestic and international)
* Education and Experience:

* B.A. or B.S. degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.). Advanced degree in life sciences (MS, PhD, etc.) and/or MBA encouraged. RAC encouraged.
* Minimum of 7 years of direct applicable regulatory experience in medical devices, IVD experience a plus. Proven leadership skills and presence.
* Minimum of 3 years managerial experience

Why join us?

A career at BD means joining a team that values your points of view and contributions and that encourages you to bring your authentic self to work. Here our associates can fulfill their lifes purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally hardworking and committed to encouraging an expansive, growth-centered, and exciting work environment. Our Total Rewards program which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components is crafted 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.

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift