Apply for Regulatory Affairs Specialist Job at Medtronic in Hyderabad. Explore responsibilities, qualifications, benefits, and application process.
Medtronic, a global leader in healthcare technology and medical innovation, is hiring for the position of Regulatory Affairs Specialist for its Hybrid workplace located in Nanakramguda, Hyderabad, India. This full-time position, listed under Job Requisition ID R43629, offers an opportunity to work with one of the world’s most influential healthcare organizations. Regulatory Affairs Specialist Job at Medtronic
Medtronic’s mission-driven culture focuses on innovation, patient outcomes, and equitable access to healthcare. A career at Medtronic gives professionals the opportunity to contribute to global healthcare transformation while growing within a supportive and development-focused environment. The Regulatory Affairs Specialist role is crucial for ensuring Medtronic’s surgical products, robotics, and digital solutions meet global regulatory standards. Regulatory Affairs Specialist Job at Medtronic
This in-depth job post provides complete details about the role, responsibilities, qualifications required, company background, benefits, and a step-by-step guide on how to apply. Regulatory Affairs Specialist Job at Medtronic
About the Role
The Regulatory Affairs Specialist will be responsible for implementing and supporting regulatory processes within the Surgical Operating Unit (OU) of Medtronic. This unit integrates Surgical Innovations and Surgical Robotics, creating a unified, strategic, and powerful division focused on developing advanced surgical technologies. Regulatory Affairs Specialist Job at Medtronic
In this position, the candidate will support global regulatory submissions, maintain compliance with quality standards, streamline documentation processes, and collaborate with cross-functional teams. This is a hybrid role requiring collaboration across teams in India and global locations, especially in the US EST time zone. Regulatory Affairs Specialist Job at Medtronic
Key Responsibilities
The Regulatory Affairs Specialist will manage essential regulatory processes supporting the Surgical OU. Responsibilities include:
1. Regulatory Liaison and Process Management
- Act as a liaison with the Operating Unit Regulatory teams to ensure the accurate application of regulatory guidelines and data attributes.
- Facilitate smooth communication and coordination between internal departments and regulatory teams.
2. Documentation Management
- Convert technical documents into Global Submission Summary Documentation (GSSD).
- Create and maintain electronic Bill of Materials (e-BOM) structure in CAP Agile for GSSD preparation.
3. Process Streamlining
- Use Artificial Intelligence and digital tools to streamline regulatory processes.
- Identify opportunities for automation and efficiency improvements.
4. Compliance and Quality Management
- Ensure compliance with multiple Quality Management Systems (QMS).
- Stay updated on evolving regulatory guidelines, international standards, and best practices.
5. Monitoring and Reporting
- Track regulatory procedures and document regulatory changes.
- Support decision-making by communicating updates, reports, and findings to internal teams.
Minimum Qualifications (Must-Have Requirements)
To qualify for the Regulatory Affairs Specialist role, candidates must meet the following criteria: Regulatory Affairs Specialist Job at Medtronic
- Bachelor’s degree in Medical Science, Mechanical Engineering, Life Sciences, or other healthcare-related fields.
- 4 to 7 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
- Ability to work independently under general supervision.
- Experience contributing to project milestones and supporting regulatory submissions.
- Ability to adjust systems, recommend enhancements, and solve complex problems.
- Strong communication skills for interacting with internal teams and coordinating information.
- Willingness to work flexible hours, especially covering US EST time zone as required.
Preferred Qualifications (Nice-to-Have Skills)
While not mandatory, the following additional skills and experience are preferred by Medtronic: Regulatory Affairs Specialist Job at Medtronic
- Strong knowledge of US and global regulatory affairs procedures.
- Experience working with cross-functional teams in engineering, quality, and clinical domains.
- Excellent verbal and written communication skills for both internal and external interactions.
- Problem-solving experience and ability to handle concerns efficiently.
- Project management skills and ability to meet deadlines.
- Ability to perform under pressure in a dynamic regulatory environment.
- High level of detail orientation, organizational skills, and task efficiency.
- Team-oriented mindset with willingness to support colleagues.
- Capability to manage cross-department projects from initiation to completion.
- Strong interpersonal, negotiation, and influencing skills.
- Desire to proactively learn and stay updated within the global regulatory landscape.
- RAPS (Regulatory Affairs Certification) from the Regulatory Affairs Professionals Society (optional but desirable).
About Medtronic
Medtronic is one of the world’s largest healthcare companies, employing more than 95,000 professionals worldwide. The organization is committed to designing advanced medical technologies and digital solutions that alleviate pain, restore health, and extend life. Regulatory Affairs Specialist Job at Medtronic
Medtronic’s culture is built on innovation, collaboration, and diversity. The company empowers employees to explore career paths, participate in learning programs, and contribute to meaningful global health outcomes.
Working at Medtronic means becoming part of a mission-driven team focused on solving the most challenging health problems. Every role—from R&D engineers to regulatory professionals—contributes to advancing healthcare technology and improving patient lives.
Benefits and Compensation
Medtronic offers a competitive and comprehensive benefits package designed to support employees at every stage of their personal and professional journey. Benefits typically include: Regulatory Affairs Specialist Job at Medtronic
- Competitive salary and performance-linked incentives.
- Access to the Medtronic Incentive Plan (MIP).
- Flexible benefits depending on employee needs.
- Supportive work environment and hybrid work flexibility.
- Health and wellness programs.
- Professional development and global training programs.
- Opportunities for cross-functional exposure and internal career mobility.
Work Conditions and Physical Requirements
For office-based roles:
- Employees must be independently mobile.
- Must be able to work with computers and collaborate with colleagues.
- Reasonable accommodations can be provided for employees with disabilities, as required.
Medtronic emphasizes safety, accessibility, and inclusiveness in all workplace conditions.
Why Choose a Career at Medtronic?
A career at Medtronic offers:
- Global exposure and the ability to work on cutting-edge medical technologies.
- Strong learning and development programs.
- Opportunity to contribute to life-saving healthcare solutions.
- Supportive leadership and collaborative work culture.
- A mission-led environment with purpose-driven work.
Medtronic encourages innovation, challenges limits, and inspires professionals to achieve excellence in healthcare. Regulatory Affairs Specialist Job at Medtronic
How to Apply for the Regulatory Affairs Specialist Position
Follow these steps to apply: Regulatory Affairs Specialist Job at Medtronic
- Visit the official Medtronic Careers website.
- Search for Job Requisition ID R43629 or the job title “Regulatory Affairs Specialist.”
- Review the job details and ensure you meet the eligibility criteria.
- Click on Apply Now to begin the application process.
- Create or log in to your Medtronic Careers account.
- Upload your resume, cover letter, and required documents.
- Submit the application and track your status through the careers portal.
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