Location: Nanakramguda, Hyderabad
Industry Type: Pharma / Healthcare / Clinical Research
Application Deadline: 30th October 2024
About Us:
At Medtronic, we are committed to pushing the boundaries of technology and innovation to alleviate pain, restore health, and extend life. Our collaborative environment encourages us to challenge each other and strive for continuous improvement. Join us in addressing universal healthcare needs and making a meaningful impact on patients’ lives.
Job Description:
We are seeking a Regulatory Affairs Specialist II to support our Design and Development Control activities. This role will involve working with various organizational departments to ensure compliance with regulatory requirements.
Key Responsibilities:
- Prepare, review, file, and support premarket documents for global registrations.
- Collaborate with business units and international regulatory personnel for marketing authorizations.
- Represent Regulatory Affairs in product development projects from concept through commercialization.
- Review pre-clinical and clinical protocols and reports for project submissions.
- Develop regulatory strategies for new or modified products.
- Monitor changes in the regulatory environment and their impact.
- Communicate with regulatory agencies on routine matters.
- Maintain communication with health authorities.
- Prepare internal documents for device modifications as needed.
- Participate in health agency inspections and audits.
- Author and review regulatory procedures.
- Assess regulatory impact on change control documents.
- Maintain regulatory files and reporting systems.
- Review promotional materials and labeling for compliance.
- Ensure compliance with regulations for product materials and prototypes.
Candidate Profile:
- Education: Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or a related healthcare field.
- Experience: 4-7 years in a regulatory affairs role within the medical device or pharmaceutical industry.
- Knowledge: Strong understanding of regulations from India, US FDA, EU, and the ability to interpret international requirements.
- Skills: Excellent written, organizational, and communication skills; flexible and team-oriented; strong attention to detail; able to manage multiple tasks under pressure; proficient in English (reading, writing, speaking).
- Attitude: Good learning mindset and willingness to adapt.
Why Join Us?
At Medtronic, you’ll be part of a team dedicated to making healthcare better for everyone. If you’re passionate about regulatory affairs and want to contribute to meaningful innovations, we encourage you to apply!
