
Regulatory Affairs Strategic Planning Program Manager
Welcome to Medtronic, a global leader in medical technology that is committed to improving the lives of patients worldwide. We are seeking a highly motivated and experienced Regulatory Affairs Strategic Planning Program Manager to join our team. In this role, you will play a critical role in developing and executing strategic plans for regulatory affairs across multiple business units. With your expertise and leadership, you will help ensure Medtronic products comply with all applicable regulations and standards. If you are passionate about making a difference in the healthcare industry and have a strong background in regulatory affairs, we want to hear from you. Join us in our mission to alleviate pain, restore health, and extend life.
- Develop and execute strategic plans for regulatory affairs across multiple business units.
- Collaborate with cross-functional teams to ensure Medtronic products comply with all applicable regulations and standards.
- Stay updated on global regulatory requirements and communicate potential impacts to the organization.
- Provide leadership and guidance to the regulatory affairs team in developing and implementing regulatory strategies.
- Act as a liaison between Medtronic and regulatory agencies, ensuring timely and effective communication.
- Monitor and assess changes in regulations and proactively identify potential risks or opportunities for the organization.
- Develop and maintain relationships with key stakeholders, both internal and external, to support regulatory initiatives.
- Participate in the development and review of regulatory submissions, ensuring accuracy and completeness.
- Provide expertise and guidance on regulatory requirements for new product development and modifications to existing products.
- Develop and maintain regulatory policies and procedures to ensure compliance with all applicable regulations and standards.
- Manage regulatory projects and timelines, ensuring timely completion and submission of regulatory deliverables.
- Participate in regulatory audits and inspections, providing support and addressing any findings or observations.
- Keep track of key performance indicators and provide regular updates to leadership on the progress of regulatory projects.
- Contribute to the development and implementation of training programs for the regulatory affairs team and other stakeholders.
- Act as a subject matter expert on regulatory affairs, providing guidance and support to other departments as needed.
Bachelor's Or Master's Degree In A Relevant Field Such As Regulatory Affairs, Business Administration, Or Healthcare Management.
Minimum Of 5 Years Of Experience In Regulatory Affairs, Preferably In The Medical Device Industry.
Strong Knowledge Of Global Medical Device Regulations And Experience Working With Regulatory Bodies Such As Fda, Ema, And Health Canada.
Proven Project Management Skills With The Ability To Develop And Execute Strategic Plans For Regulatory Compliance.
Excellent Communication And Leadership Skills With The Ability To Collaborate With Cross-Functional Teams And External Stakeholders.
Quality Assurance
Project Management
Risk assessment
Regulatory compliance
Market analysis
FDA regulations
Stakeholder management
Cross-Functional Collaboration
Clinical Trials
Product Registration
Global Strategy
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
Decision-making
According to JobzMall, the average salary range for a Regulatory Affairs Strategic Planning Program Manager is $120,000 to $150,000 per year. This may vary depending on the specific industry, company, and location. Some positions may offer higher salaries, especially for those with extensive experience and advanced degrees.
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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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