Medtronic, a global leader in medical technology, is committed to improving healthcare access and equity worldwide. The company fosters innovation, collaboration, and compassion, ensuring a connected healthcare system. By joining Medtronic, you’ll embark on a lifelong journey of exploration and purposeful leadership, breaking barriers to improve patient lives.
Responsibilities in the Job
As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring regulatory compliance and supporting Medtronic’s operations in India. Your responsibilities will include:
- Preparing, submitting, and following up on approvals, renewals, and variations of medical devices across various business units.
- Coordinating and preparing document packages for regulatory submissions and internal audits.
- Monitoring and improving tracking/control systems for compliance.
- Providing technical guidance on federal and local regulatory requirements as they apply to products, processes, and labeling.
- Leading interactions with regulatory agencies and recommending strategies for the earliest possible approval of clinical trial applications.
- Offering recommendations for labeling, marketing, and manufacturing for regulatory compliance.
Qualifications
To be successful in this role, you should meet the following criteria:
- Educational Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Bio-Medical Engineering, or a Science discipline with training in Regulatory Affairs.
- Experience:
- 3-6 years in the pharma, medical device, or life science industry.
- At least 2-3 years in medical device regulatory affairs.
- Regulatory Knowledge:
- Familiarity with CDSCO, FDA, CE, and other regulatory requirements.
- Expertise in medical device registration, import, clinical trials, and quality systems.
Skills
Medtronic values professionals with the following skills:
- Technical Skills:
- Knowledge of regulatory systems and design controls.
- Application of regulatory guidelines to project lifecycles.
- Soft Skills:
- Excellent communication and interpersonal abilities.
- Customer-focused mindset with a proactive “can-do” attitude.
- Strong problem-solving and team collaboration skills.
- Language Skills:
- Proficiency in English for verbal and written communication.
