Regulatory Affairs Specialist - Neuro

Are you passionate about making a difference in the world of healthcare? Do you have a strong background in regulatory affairs and a deep understanding of the neurology industry? Medtronic, a global leader in medical technology, is seeking a highly skilled and motivated Regulatory Affairs Specialist to join our Neuro team. This role offers the opportunity to play a crucial role in bringing innovative treatments to patients with neurological conditions. We are looking for a detail-oriented and collaborative individual who is dedicated to ensuring compliance with regulations and driving successful product approvals. If you are ready to make a meaningful impact and be a part of an innovative team, then this could be the perfect opportunity for you.

1. Develop and maintain a thorough understanding of regulations and guidelines related to the healthcare industry, specifically in the field of neurology.
2. Collaborate with cross-functional teams, including R&D, clinical, and marketing, to ensure regulatory compliance throughout the product development process.
3. Prepare and submit regulatory submissions, including 510(k)s, PMAs, and international registrations, in a timely and accurate manner.
4. Communicate with regulatory agencies to address and resolve any issues or questions related to submissions or product approvals.
5. Monitor changes in regulations and update internal teams on potential impact to product development and approval processes.
6. Conduct regulatory research and provide guidance on compliance requirements for new product concepts and modifications to existing products.
7. Participate in internal and external audits to ensure compliance with regulations and company standards.
8. Collaborate with other departments to ensure labeling and promotional materials are in compliance with regulations.
9. Maintain accurate and up-to-date records and documentation related to regulatory submissions and approvals.
10. Continuously evaluate and improve internal processes related to regulatory affairs to streamline and improve efficiency.
11. Act as a subject matter expert on regulatory affairs matters and provide guidance and training to internal teams as needed.
12. Represent the company at industry conferences and meetings to stay informed on industry trends and regulations.
13. Adhere to ethical standards and maintain confidentiality of sensitive information at all times.
14. Actively participate in team meetings and provide input and feedback on regulatory strategies and processes.
15. Stay current on industry best practices and share knowledge and insights with the team to drive continuous improvement.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist - Neuro in Minneapolis, MN, USA is $66,000 - $109,000 per year. This may vary depending on the specific company, level of experience, and other factors. Some companies may also offer bonuses, benefits, and other forms of compensation in addition to the base salary.

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.