Senior Regulatory Affairs Program Manager
Welcome to Medtronic, a global leader in medical technology and innovation. We are currently seeking a highly skilled and experienced Senior Regulatory Affairs Program Manager to join our team. As a Senior Regulatory Affairs Program Manager, you will play a key role in ensuring compliance with regulatory requirements and driving successful product submissions to global regulatory bodies. This is an exciting opportunity for a results-driven individual who is passionate about making a positive impact in the healthcare industry. If you possess a strong background in regulatory affairs and have a track record of successfully managing complex programs, we encourage you to apply.
- Develop and implement regulatory strategies to ensure compliance with global regulations and standards.
- Lead and manage the preparation, submission, and maintenance of regulatory submissions for new and existing products.
- Stay up-to-date with changes in global regulatory requirements and communicate any potential impact to the company.
- Collaborate with cross-functional teams to ensure timely and accurate completion of regulatory submissions.
- Review and approve product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
- Provide guidance and support to project teams on regulatory matters and serve as the main point of contact for regulatory agencies.
- Conduct risk assessments and develop mitigation plans to address potential regulatory issues.
- Monitor and track the progress of regulatory submissions and communicate any delays or issues to management.
- Manage relationships with regulatory agencies and participate in meetings and audits, as needed.
- Serve as a subject matter expert on regulatory affairs and provide training and guidance to team members, as needed.
- Identify opportunities for process improvements and implement best practices for regulatory submissions.
- Ensure compliance with internal quality systems and procedures related to regulatory affairs.
- Collaborate with cross-functional teams to develop and maintain regulatory strategies for new product development.
- Provide support for post-market surveillance and adverse event reporting activities.
- Act as a mentor and coach to junior regulatory affairs team members.
Advanced Degree In Regulatory Affairs Or Related Field: A Senior Regulatory Affairs Program Manager At Medtronic Should Have A Minimum Of A Master's Degree In Regulatory Affairs, Biomedical Sciences, Or A Related Field. This Will Ensure That The Candidate Has A Strong Understanding Of The Complex Regulatory Landscape And Can Effectively Lead Regulatory Programs.
Extensive Experience In Medical Device Industry: Medtronic Is A Leading Global Medical Device Company, And A Senior Regulatory Affairs Program Manager Should Have A Minimum Of 7-10 Years Of Experience In The Medical Device Industry. This Experience Should Include Direct Involvement In The Regulatory Affairs Department, With A Deep Understanding Of Global Regulations And Guidelines.
Strong Leadership And Project Management Skills: As A Senior Regulatory Affairs Program Manager, The Candidate Will Be Responsible For Leading A Team Of Regulatory Professionals And Managing Multiple Projects Simultaneously. Therefore, Strong Leadership And Project Management Skills Are Essential Qualifications For This Role.
In-Depth Knowledge Of Global Regulations And Guidelines: Medtronic Operates In Multiple Countries, And A Senior Regulatory Affairs Program Manager Should Have A Deep Understanding Of Global Regulations And Guidelines, Including Fda, Eu, And Other International Regulatory Bodies. This Knowledge Is Crucial In Ensuring Compliance And Successful Submissions.
Excellent Communication And Collaboration Skills: A Senior Regulatory Affairs Program Manager At Medtronic Will Be Required To Communicate Effectively With Cross-Functional Teams, Regulatory Agencies, And External Partners. Therefore, Strong Communication And Collaboration Skills Are Essential For Success In This Role.
Quality Assurance
Project Management
Data Analysis
Communication
Team Management
Leadership
Global regulations
Strategy development
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Product Registration
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Program Manager in Minneapolis, MN, USA is between $125,000 and $150,000 per year. This may vary depending on the specific industry, company, and level of experience of the individual.
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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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