Regulatory Affairs Manager
India Medtronic Pvt. Ltd
Work from Office
Full Time
Min. 15 yearsJob Description
Regulatory Affairs Manager
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
The Regulatory Affairs function at Medtronic Engineering & Innovation Center (MEIC) supports global regulatory activities that enable the development, registration, and lifecycle management of medical technologies. This team partners with cross-functional stakeholders to develop regulatory strategies, support product submissions, maintain regulatory compliance, and ensure alignment with evolving global regulatory requirements across the medical device portfolio.This position is based in Nanakramguda, Hyderabad, India and follows a Flexible Work Arrangement model. Limited domestic and international travel may be required to support business objectives, regulatory activities, and stakeholder collaboration.
- Lead and develop a Regulatory Affairs team responsible for supporting global regulatory submissions, registrations, renewals, and compliance activities.
- Oversee the preparation, review, and coordination of regulatory documentation packages to support product approvals and lifecycle management activities.
- Develop and execute regulatory strategies that align with business objectives and applicable global regulatory requirements.
- Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
- Monitor changes in global regulatory regulations, standards, and guidance documents and assess business impact.
- Drive continuous improvement initiatives to enhance regulatory processes, documentation quality, operational efficiency, and compliance tracking systems.
- Provide leadership during regulatory inspections, audits, agency interactions, and compliance-related activities.
- Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related scientific discipline and 15+ years of regulatory affairs experience within the medical device or pharmaceutical industry.
- Minimum 5 years of people leadership experience managing medium to large regulatory, quality, or compliance-focused teams.
- Demonstrated experience supporting regulatory submissions, registrations, compliance activities, and regulatory lifecycle management.
- Working knowledge of global medical device regulatory requirements and regulatory agency interactions.
- Effective verbal and written communication skills with the ability to collaborate across global cross-functional teams.
- Advanced degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
- Experience leading global Regulatory Affairs teams within a multinational medical device organization.
- Demonstrated success driving process improvements, operational excellence programs, and regulatory compliance initiatives.
- Experience supporting regulatory inspections, audits, and interactions with international regulatory authorities.
- Strong analytical skills with experience using technology and reporting tools to support regulatory metrics, tracking, and decision-making.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Experience Level
Senior LevelJob role
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