Regulatory Affairs Manager - International at Medtronic

Posted in General Business 2 days ago.

Type: Full-Time
Location: Minneapolis, Minnesota

Job Description:


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

The Regulatory Affairs Manager - International will report directly into the Vice President of Regulatory Affairs for the Pelvic Health and Neuromodulation Operating Units (OUs). This position is responsible for establishing strategy for and supporting execution of global regulatory activities for obtaining and maintaining Pelvic Health and Neuromodulation product regulatory approvals in countries outside the United States. This position is responsible to implement policies, procedures, practices and strategies for global Regulatory Affairs submissions and approvals. These responsibilities are performed through the collaboration with various functions within the Operating Units (including, but not limited to Regulatory Affairs, Research and Development, and OU/Global Marketing), as well as regional Regulatory Affairs departments. Goals and performance objectives are achieved through hands on and delegation of responsibilities to individual contributors.

A Day In The Life

The Regulatory Affairs Manager - International is responsible for managing the work priorities and career development of six or more direct reports who are focused on tactical, operational and some strategic activities pertaining to obtaining and maintaining global regulatory product approvals. Management responsibilities include managing performance, developing talent, driving engagement and inclusion, communicating business and operational requirements, and project planning.

This position is based at the Medtronic Fridley, MN office, but will be virtual for the foreseeable future.

  • Provides direction, leadership and coaching to staff to meet schedules and resolve technical or operational problems. As necessary, becomes actively involved in daily operations to meet schedules or to resolve complex problems.
  • Develop global regulatory strategies for Pelvic Health and Neuromodulations products to meet business objectives and collaborates across a matrixed organization to ensure global availability of products.
  • Participate on Product Development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
  • Participate in the product change assessments and define regulatory impact of product changes in global markets.
  • Review and approve labeling, training, promotional, and advertising material, as directed.
  • Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
  • Implement/maintain procedures and drive process and system improvements to increase department efficiencies.
  • Support post-market activities (e.g. CAPA, issue assessment), as directed.
  • Actively monitor a high-performance management culture where employees have clear performance objectives and expectations.
  • Provide targeted career coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.
  • Conduct timely and candid performance evaluations. Support meaningful career development activities.

    Must Have; Minimum Requirements

    • Bachelor's Degree required. Engineering or Advanced degree desired.
    • Minimium 5 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
    • Or a minimum of 3 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility

    Nice To Have

    • 2+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
    • Experience managing a Regulatory Affairs international function
    • Excellent knowledge of European/International regulations and standards
    • Experience interacting with regulatory agencies
    • Proven ability to prioritize, conduct, and manage time to meet project deadlines
    • Demonstrated ability to work well in dynamic and cross functional team environments
    • Demonstrated collaboration and leadership skills in team setting
    • Solid understanding of manufacturing and change control, and an awareness of regulatory trends
    • Experience reviewing design specifications and other technical documents
    • Interpret new and changing international regulatory requirements, communicate impact to stakeholders, and support development of implementation plans
    • Excellent interpersonal and communication skills, both oral and written
    • Documented evidence of writing skills
    • Working understanding of computer applications; proficient in Microsoft Office Applications
    • Familiarity with medical terminology
    • Some overnight travel required

    About Medtronic

    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

    We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

    Physical Job Requirements

    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

    A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

    Learn more about our benefits:

    This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .

    Additional Information

    • Posting Date: Sep 13, 2021
    • Travel: No

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