Faça parte de algo maior na BD. Aqui, você nos ajudará a manter nossos altos padrões de uma perspectiva regulatória em todos os níveis, com foco nas submissões. Requer atenção aguda aos detalhes, excelentes habilidades de comunicação e uma paixão para continuar aprendendo e atualizando seu conhecimento, o que o ajudaremos a fazer com oportunidades regulares de aprendizado. Aqui, você usará seu profundo conhecimento das regulamentações e requisitos da FDA, Canadá e ISO/MDD em torno de dispositivos médicos para atingir um objetivo único: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Job Description Summary
As Associate Director, Regulatory Affairs, you will be responsible for managing a team that develops and executes the strategy and timelines for submission of various regulatory licensing activities for new and currently marketed products.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 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:
Serves as primary regulatory body liaison including managing audits, responses, and new submissions, and RA leadership team representative.
Responsible for the global regulatory strategy for UCC products
Leads the RA function on assigned complex, cross-functional project teams; establishes appropriate communication within RA and other functions at project and upper management levels.
Provides regulatory strategy, risk evaluation and mitigation recommendations to project teams; develops and documents sound regulatory decisions and justifications for complex and high-risk facility, product, and process changes.
Ensures project team and business objectives and deliverables are aligned with regulatory strategy and submission timelines.
Orchestrates the format and information in the development and execution of regulatory submissions.
Ensures accuracy of Clinical documents in compliance with Clinical Trial regulations for submission to FDA for execution of Clinical Studies.
Provides guidance and coaching to maintain effective collaboration as a Global RA team and to synchronize domestic and international submissions.
Proposes gap analysis of proposed and implemented regulatory guidance documents and regulations to propose solutions.
Provides direct supervision of individuals.
Provides guidance on development and review of labeling and promotional material for compliance with regulations; works closely with Legal and clinical team to ensure compliance with regulatory requirements.
Presents regulatory project updates, risks and regulation or guidance changes to Corporate Quality and Regulatory Affairs. International Regulatory Affairs and Senior Leadership.
About you: To be successful in this role, you require:
Minimum BA or BS required, preferably in a scientific or health related discipline.
Minimum 10 years’ experience in Regulatory Affairs, and/or a combination of Regulatory Affairs and Quality Assurance within the Medical Device industry.
Knowledge of healthcare-related regulatory bodies such as FDA, Notified Bodies, Health Canada, TGA, etc.
Understanding of related disciplines in an FDA regulated organization.
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. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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 GA - Covington BMDAdditional Locations
Work Shift
Perfil de Sucesso
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Apresentador habilidoso
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.