- 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
- 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)
- Minimum:
- 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.
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Staff Regulatory Affairs Specialist - Franklin Lakes, United States - BD (Becton, Dickinson and Company)
Description
Job Description Summary
The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the project level in developing and executing regulatory strategy and compliance plans to promote and support drug delivery solutions for pharma combination product development.
The incumbent will represent the RA function on designated platform core team implementing regulatory strategies to support cross-functional stand-alone medical device and combination product development efforts for platform growth and global expansion.
This is an excellent opportunity to lead and gain hand on experience in regulatory field with Business-to-Business customer exposure, US, EU and global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management.
Job 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 its no small feat.
It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll be supported to learn, grow and become your best self. Become amaker of possible
with us.
Responsibilities
About you:
To be successful in this role, you require:
Education and experience required:
For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID-19.
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.
Its also a place where we help each other be great, we do whats 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.
To learn more about BD visit?
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.
PDN
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
NA (United States of America)
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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