Senior Regulatory Compliance Manager

2 days ago

Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time US$ 1,00,000 - US$ 1,55,000

At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. As a Staff Associate Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements for our medical devices.

This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. You will participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, lead interactions with regulatory agencies and notified bodies, review design control documents and product labeling, and evaluate proposed device changes.

You will interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provide recommendations to minimize risk. This includes representing 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.

Key responsibilities include evaluating medical device regulations, leading development of global regulatory strategies, reviewing and approving design control documentation and product labeling, authoring FDA submissions, EU technical files, and other regulatory documents, leading interactions with FDA, EU notified bodies, and other regulatory agencies, independently reviewing product changes to ensure regulatory compliance, communicating changes to global regions, and supporting preparation of global notifications.

This role requires a Bachelor's degree or higher, preferably in a scientific discipline, and Master's degree in Regulatory Affairs preferred. Regulatory Affairs Professional Society (RAPS) certification is also preferred. Six to eight years of experience in the medical device industry, including leadership roles, is required.

The ideal candidate will have excellent written and verbal communication skills, negotiation skills, ability to manage multiple tasks and meet timeline commitments, detail-oriented, able to analyze, interpret, and review scientific, technical, and regulatory information, comprehensive understanding of global medical device regulations, and working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.

We offer competitive compensation and benefits packages, as well as opportunities for career growth and professional development. Our company values diversity, equity, and inclusion, and we strive to create a work environment that is welcoming and supportive of all employees. We are committed to making a positive impact on society through our products and services.

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