Regulatory Affairs Specialist- II-ET

Are you a highly motivated and detail-oriented individual with a passion for ensuring regulatory compliance in the medical industry? Do you thrive in a fast-paced environment and have a strong understanding of regulatory requirements for medical devices? If so, Medtronic has an exciting opportunity for you to join our team as a Regulatory Affairs Specialist II-ET.As a Regulatory Affairs Specialist II-ET, you will play a crucial role in ensuring that Medtronic's medical devices and products meet all regulatory requirements and standards. You will work closely with cross-functional teams to develop, implement, and maintain regulatory strategies and submissions for new and existing products.To be successful in this role, you must have a bachelor's degree in a related field and at least 3-5 years of experience in regulatory affairs within the medical device industry. You should also have strong communication and project management skills, as well as a deep understanding of FDA regulations and international standards.If you are looking for a challenging and rewarding career in regulatory affairs, we encourage you to apply for this position at Medtronic. Join us in our mission to improve the lives of patients worldwide through innovative medical technologies.

1. Develop and maintain regulatory strategies for new and existing medical devices and products.
2. Collaborate with cross-functional teams to ensure compliance with all relevant regulations and standards.
3. Prepare and submit regulatory submissions to health authorities, including 510(k) and PMA applications.
4. Monitor changes in regulations and standards and provide guidance to internal teams on potential impact.
5. Conduct risk assessments and develop risk mitigation strategies to ensure product safety and compliance.
6. Review and approve labeling, advertising, and promotional materials for compliance with regulatory requirements.
7. Provide regulatory guidance and support to other departments, such as R&D, quality, and clinical affairs.
8. Participate in regulatory agency inspections and audits.
9. Maintain and update regulatory documentation and provide timely and accurate responses to regulatory inquiries.
10. Keep up-to-date with industry trends and best practices in regulatory affairs.
11. Represent the company in meetings and communications with regulatory agencies.
12. Participate in the development and implementation of regulatory training programs for employees.
13. Collaborate with international regulatory teams to ensure global product registrations and compliance.
14. Identify and communicate potential regulatory risks and issues to management.
15. Adhere to company policies and procedures, as well as applicable laws and regulations.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist- II-ET in Nanakramguda, Telangana 500032, India is approximately $60,000 to $80,000 per year. This may vary based on factors such as experience, education, and the specific company or organization. Additionally, location can also play a role in the salary range for this position.

Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.