Senior Regulatory Affairs Specialist (Hybrid)
Job Description Summary
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.
Senior Regulatory Affairs Specialist position is dedicated to the Reusable Pen Platform and its 2 strategic customers with BD for Pen registered in over 60 countries.
This is an excellent opportunity gain hand on experience in regulatory field with Business-to-Business customer exposure, global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management.
General Function: Drive Global implementation and customer deliverables for Reusable Pen platform per PS RA team Strategy
Acts as a RA Core team Member (RA CTM) and handle timely execution of strategies, WW registrations and customer deliverables as assigned by RA Manager and Platform leader
Partners with customers to implement end to end activities, such as documentations, submissions and addressing health authority questions for new and renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant files and supporting documentation (EUMDR technical files/510k/ US master files/international technical dossiers) in WW market
Performs impact assessment of changes related to design, improvements and management of supplement/notification/change submissions for timely implementation
Effective Collaboration with collaborators i.e. internal teams (PS cross functional, BD corporate), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada) for requirements and documentation to support registrations, project results and audit folders.
Support multiple projects with attention to detail for health authority submissions and support internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Maintains knowledge & awareness on applicable regulations and standards. Perform regulatory intelligence/watch, impact assessment and guide/support appropriate collaborators with adoption and timely compliance implementation.
Identify ways to improve the efficiency of current work process, SOP and best practices as needed.
B.S. degree in a technical subject area (e.g., pharmacy, engineering, biology, chemistry).
Advanced degree plus.
RAPS certification is plus
Bachelors degree and Minimum of 5 years of directly related professional experience in medical device (regulatory submissions, compliance or project management)
Alternatively, Master’s degree and Minimum of 3 years of directly related work experience in medical device (regulatory submissions, compliance or project management)
US, EU , and international Medical device registration experience is preferred. Pharmaceutical, biologics, Combination Products experience is a plus.
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
About you: To be successful in this role, you will require:
Deep understanding of EUMDR, MDSAP, product development cycle, change management, design control, organizational change, quality management systems and audit readiness
Strong communication (verbal, written) and experience in meeting with, making presentations to, and negotiating with leadership and/or Health authorities
Ability to use your time productively and efficiently (structured and self-organized. project management skills a plus)
Ability to independently handle multiple tasks/projects with minimum supervision
Flexible, accountable, and reliable personality; Attention to details and ability to resolve problems and to make appropriate and timely regulatory decisions under pressure
Ability to adapt, multitask and respond quickly in a constantly evolving and often ambiguous environment
High personal integrity and ethical standards; Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)
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.
Primary Work LocationUSA NJ - Franklin Lakes
Work ShiftNA (United States of America)
Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ