Sea parte de algo más grande en BD. Aquí, nos ayudará a compartir nuestras soluciones innovadoras con más clínicas, médicos, farmacias y entidades médicas que, a su vez, beneficiarán la salud y el bienestar de las personas y los pacientes de todo el país. Es un puesto emocionante, desafiante y gratificante, pero trabajará desde una posición sólida gracias a nuestro nombre de confianza y la convicción que desarrollará rápidamente en nuestros productos . Aquí, canalizará todas sus habilidades y experiencia en ventas hacia un único objetivo: impulsando el mundo de la salud™. En BD, puede hacer una verdadera diferencia.
Responsibilities
Job Description Summary
Job Description
Bachelor's degree or higher, preferably in a scientific discipline
Master's degree in Regulatory Affairs preferred
Regulatory Affairs Professional Society (RAPS) certification preferred
4-6 years Regulatory Affairs experience in the medical device industry
>Excellent communication and organization skills
>Excellent problem solving and analytical skills
>Detail-oriented, with focus on accuracy and completeness
>Ability to manage multiple tasks and meet timeline commitments
>Ability to work in a team-oriented, fast-paced environment
>Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information
>Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
>Experience working with FDA, EU notified bodies, and other regulatory agencies
>Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
>Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.
>Experience with product development processes and design control.
>Mentor/teach
>Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies.
>Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)
The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
>Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met.
>Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market.
>Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements.
>Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval.
>Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues.
>Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications.
>Communicates changes to global regions and supports preparation of global notifications as needed.
Primary Work Location
IND Bengaluru - Technology CampusAdditional Locations
Work Shift
Success Profile
¿Qué hace exitoso a un Profesional de Asuntos Regulatorios en BD? Echa un vistazo a los principales rasgos que estamos buscando y mira si tienes la combinación adecuada.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Presentador experto
Avances en el mundo de la salud™
BD es una de las compañías de tecnología médica más grandes del mundo y está mpulsando el mundo de la salud™ al mejorar el descubrimiento médico, el diagnóstico y la entrega de cuidado. BD ayuda a los clientes a mejorar los resultados, reducir los costos, aumentar la eficiencia, mejorar la seguridad y ampliar el acceso a la atención médica.