Staff Regulatory Affairs Specialist
2 months ago
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.
Responsibilities
Acts as a RA Core team Member (RA CTM) and works with RA Manager and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer results
Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers’ regulatory submissions
Authoring and maintenance of compliant regulatory files and supporting documentation (510k/ US master files/EUMDR technical files)
Partners with and supports Pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals
Performs regulatory impact assessment of changes linked to the field of expertise and assigned platform
Liaises with cross-functional and cross company teams to meet customer needs in driving new global markets
Develops and maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners
Identifies and communicates potential risks and mitigations to partners
Support to customers for regulatory advice and registration of their products and interact as needed with the U.S. FDA and EU Notified Bodies
Reviews and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling
Conduct trainings on regulatory issues for staff and for business customers (e.g., Platform, R&D, Marketing and Pharma Partners)
Participates in internal/external trade, professional, and standards development organizations
Leads multiple projects with minimal direction
About you:
To be successful in this role, you require:
Knowledge in pharmaceutical and medical devices regulation registration requirements and pathways (variations, renewals, supplements), in the US and EU markets. Global experience is a plus.
Understanding of new product development cycle, clinical phases, organizational change and quality management systems compliance
Experience with Eletromechanical devices. Knowledge of SaMD and drug delivery devices (on-body injector, pumps, pen injector, auto-injector) and pre-fillable syringes is preferred.
Experience in meeting with, making presentations to, and negotiating with senior leadership and/or health authorities
Ability to use your time productively and efficiently (structured and self-organized with strong project management skills)
Ability to resolve problems and to make appropriate regulatory decisions under pressure
Ability to adapt, multitask and respond quickly in a constantly evolving and often unique, ambiguous environment, Strong team player.
Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)
Education and experience required:
Minimum: B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
Professional Certification (s) is preferred (RAPS-RAC, PMP, ASQ etc)
Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields
Proven experience with project management, negotiation, influencing and interpersonal skills.
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.
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