Senior Regulatory Affairs Specialist

Medtronic plc; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Medtronic plc in Hyderabad, India is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for international registrations. You will prepare and file global submissions, maintain documentation, and collaborate with product teams and health authorities to ensure compliance.

The role requires a Bachelor’s degree in healthcare-related fields and 7+ years of regulatory experience in medical devices or pharmaceuticals, with strong communication and project management skills.

Qualifications

• A Bachelor’s degree in medical, mechanical, electric life science or other healthcare related majors.
• 7+ years’ experience for RA role in medical device and/or pharmaceutical industry.
• Ability to work independently with general supervision on larger, moderately complex projects/assignments.
• Experience preparing and filing global regulatory submissions and documents.
• Strong communication and coordination with internal teams and health authorities.

Responsibilities

• Prepare and assemble document packages for international regulatory submissions.
• Maintain regulatory files, data, records, and reporting systems.
• Collaborate with business units and international regulatory personnel to support registrations.
• Lead development/maintenance of regulatory procedures and change controls.
• Interact with regulatory agencies on defined matters.
• Monitor regulatory environment changes and communicate impacts.

Skills

Regulatory affairs

Medical devices

Pharmaceuticals

Document management

Regulatory submissions

Communication

Education

Bachelor's degree in healthcare fields

Tools

Regulatory Information Management System

Job description

## Senior Regulatory Affairs SpecialistApplyremote type: Flexible Work Arrangementlocations: Nanakramguda, Hyderabad, Indiatime type: Full timeposted on: Posted Todayjob requisition id: R72459Careers 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**Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections**Responsibilities may include the following and other duties may be assigned:*** Set up new process for entering new data - Regulatory Information Management System.* Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes.* Keeps abreast of regulatory procedures and changes.* Provide requested regulatory data and documents to support tenders* Keeps abreast of regulatory procedures and changes.* Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.* Prepare, review, file, and support premarket documents for global registrations for assigned projects.* Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.* Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.* Compiles all materials required in submissions, license renewal and annual registrations.* Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.* Monitors and improves tracking/control systems.* May direct interaction with regulatory agencies on defined matters.* Develop Regulatory Strategies for new or modified products for assigned projects.* Monitor and provide information pertaining to impact of changes in the regulatory environment.* Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.* Document, consolidate, and maintain oral and written communication with health authorities.* Prepare internal documents for modifications to devices, when appropriate.* Author and/or review regulatory procedures and update as necessary.* Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.**Required knowledge and experience:*** Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors.* 7+ year’s experience for RA role in medical device and or pharmaceutical industry.* Works independently with general supervision on larger, moderately complex projects / assignments.* Contributes to the completion of project milestones.* Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.* Ability to quickly establish credibility with all levels of customer base.* Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making. Nice To Have Skills:* Excellent communication and interpersonal skills.* Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.* Self-motivated and positive.* Ability to quickly establish credibility with all levels of customer base.**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 [e-mail].# **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).### Who We AreWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.### What We Do**We change lives**. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.**We build extraordinary solutions as one team**. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.**This life-changing career is yours to engineer**. By bringing your ambitious ideas, unique perspective and contributions, you will...* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning### How We Are DifferentThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.**Better outcomes for our world**. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.**Insight-driven care**. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in careIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.For updates on job applications, please go to the candidate login page and sign in to check your application status.If you need assistance completing your application please email [e-mail]