Manager, Regulatory Affairs - Hybrid

Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat.

It takes the imagination and passion of all of us from design and engineering to the manufacturing and marketing of our billions of MedTech products per year to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self.

Become a maker of possible with us.

Key responsibilities will include :

Provides pre-market regulatory leadership to MMS-PA business

Directs premarket regulatory affairs activities which may include interactions between MMS-PA and Notified Body, as well as government agencies outside of the US and EU as required

Contributes to the development of MMS-PA strategic and operational plans; regulatory pathways and risks, and sound regulatory programs

Ensures functional excellence to achieve timely worldwide clearance, approval, registration, and licensure.

Responsible for talent development for the MMS-PA premarket Regulatory Affairs group; supervises and mentors RA associates

Plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to MMS-PA

Works with cross functional teams, coordinates, directs and advises the preparation of global regulatory dossier and submissions, including EU Technical Files for CE mark (e.

g., Machinery Directive), and materials required for global registration of products and monitors and guides associate submission activities.

Provides high degree of regulatory expertise and experience to MMS-PA’s new product development programs, serving as a Core Team advisor and champion for MMS-PA’s Global Product Development System (GPDS)

Serves as a regulatory expert for labeling and promotional materials review, supports regulatory standards development, experimental designs, and data analysis as they relate to registration and commercialization of PA products

Instills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellence

About you : To be successful in this role, you require :

Experienced knowledge in US and global electrical equipment regulations

Demonstrated ability to perform critical thinking at a high level of proficiency, able to exercise independent judgement and discretion within a broadly defined range of policies and practices

Demonstrated ability to deliver desired outcomes via innovative ideas and approaches

Advanced verbal, written, presentation and negotiation skills

Leads multiple long-term complex, projects without direct supervision

Excellent leadership skills with ability to develop, influence and lead others

Experienced with continuous improvement projects, project management, product development processes, and design control

Education and Experience :

B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.)

MS degree in health science, regulatory affairs, or applicable discipline a plus

RAC / RCC Certification preferred

Minimum 4 years directly applicable recent regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.

in a medical device company, and a minimum of 4 years in regulatory affairs or a related discipline

Minimum of 2 years of people management 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 encourages you to bring your authentic self to work.

It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health.