Senior Regulatory Affairs Specialist
At Medtronic, we are committed to improving the lives of people around the world by developing innovative medical technologies. As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products meet all regulatory requirements and standards. We are seeking a highly skilled and experienced individual who is passionate about making a difference in the healthcare industry. If you are a motivated self-starter with a strong understanding of global regulatory processes and a proven track record of success, we encourage you to apply for this exciting opportunity.
- Ensure compliance with all global regulatory requirements and standards for Medtronic products.
- Develop and maintain strong relationships with regulatory agencies and stay updated on any changes in regulations.
- Review and interpret regulatory guidelines and communicate any updates or changes to relevant departments within the company.
- Prepare and submit regulatory submissions, including premarket notifications, product registrations, and post-market reports.
- Conduct regulatory assessments and provide guidance to cross-functional teams to ensure products meet all necessary requirements.
- Collaborate with internal teams, including R&D, Quality, and Clinical Affairs, to ensure regulatory compliance is considered throughout all stages of product development.
- Participate in regulatory audits and inspections, providing necessary documentation and responses.
- Monitor and track product registrations and maintain necessary documentation for regulatory compliance.
- Stay updated on industry trends and changes in regulations to inform and advise on potential impact on Medtronic products.
- Mentor and train junior regulatory affairs team members and provide support and guidance as needed.
- Continuously improve and streamline regulatory processes to ensure efficiency and effectiveness.
- Maintain accurate and up-to-date records of all regulatory activities and submissions.
- Represent Medtronic in industry conferences and meetings related to regulatory affairs.
- Adhere to all company policies, procedures, and ethical standards.
Minimum Of 5 Years Experience In Regulatory Affairs Within The Medical Device Industry, Preferably With A Focus On Class Iii Devices.
Bachelor's Degree In A Related Field Such As Science, Engineering, Or Regulatory Affairs. Advanced Degree Preferred.
In-Depth Knowledge Of Fda Regulations And International Medical Device Regulatory Requirements, Including Iso 13485 And Mdr.
Proven Track Record Of Successfully Leading And Managing Regulatory Submissions For New Product Approvals, As Well As Maintaining Existing Product Registrations.
Strong Communication And Interpersonal Skills, With Experience In Effectively Collaborating With Cross-Functional Teams And Interacting With Regulatory Agencies.
Risk Management
Quality Assurance
Technical Writing
Regulatory compliance
Cross-Functional Collaboration
Clinical Trials
Product Registration
Regulatory Strategy
Medical Device Regulations
Labeling And Packaging
Global Submissions
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Boston, MA, USA is $96,000 to $130,000 per year. This may vary depending on the specific company, industry, years of experience, and other factors.
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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.
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