Medtronic

Regulatory Affairs Strategic Planning Program Manager

Medtronic

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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.

  1. Develop and execute strategic plans for regulatory affairs across multiple business units.
  2. Collaborate with cross-functional teams to ensure Medtronic products comply with all applicable regulations and standards.
  3. Stay updated on global regulatory requirements and communicate potential impacts to the organization.
  4. Provide leadership and guidance to the regulatory affairs team in developing and implementing regulatory strategies.
  5. Act as a liaison between Medtronic and regulatory agencies, ensuring timely and effective communication.
  6. Monitor and assess changes in regulations and proactively identify potential risks or opportunities for the organization.
  7. Develop and maintain relationships with key stakeholders, both internal and external, to support regulatory initiatives.
  8. Participate in the development and review of regulatory submissions, ensuring accuracy and completeness.
  9. Provide expertise and guidance on regulatory requirements for new product development and modifications to existing products.
  10. Develop and maintain regulatory policies and procedures to ensure compliance with all applicable regulations and standards.
  11. Manage regulatory projects and timelines, ensuring timely completion and submission of regulatory deliverables.
  12. Participate in regulatory audits and inspections, providing support and addressing any findings or observations.
  13. Keep track of key performance indicators and provide regular updates to leadership on the progress of regulatory projects.
  14. Contribute to the development and implementation of training programs for the regulatory affairs team and other stakeholders.
  15. Act as a subject matter expert on regulatory affairs, providing guidance and support to other departments as needed.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • 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.

Required Skills
  • Quality Assurance

  • Project Management

  • Risk assessment

  • Regulatory compliance

  • Market analysis

  • FDA regulations

  • Stakeholder management

  • Cross-Functional Collaboration

  • Clinical Trials

  • Product Registration

  • Global Strategy

Soft Skills
  • Communication

  • Emotional Intelligence

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Decision-making

Compensation

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.

Additional Information
Medtronic is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedDecember 11th, 2024
Apply BeforeJuly 20th, 2025
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About Medtronic

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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