10 days old

Regulatory Affairs Manager - Neurovascular

Irvine, CA 92606
  • Job Code

In the Neurovascular Operating Unit we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at: https://www.medtronic.com/us-en/e/neurovascular.html

Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career.

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 will report directly to the Director of Regulatory Affairs in Neurovascular (NV) BU and is responsible for establishing strategy for worldwide product approval submission activities and maintaining global regulatory compliance for NV products. The Regulatory Affairs Manager is expected to accomplish results through managing and mentoring a team of RA specialists. This role will require collaboration with cross functional business partners to develop regulatory strategies in support of business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Provides direction, leadership and coaching to RA specialists to meet schedules and resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
  • Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products.
  • Mentor RA specialists that participate on core teams, reviewing regulatory strategy and timelines.
  • Provide guidance and feedback to ensure high quality pre and post market submissions for global markets to support new product approvals and product renewals.
  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
  • Collaborate with international RA partners to align on regulatory impact of product changes in global markets.
  • Review and approve promotional and advertising material.
  • Ensure product files are compliant with Medtronic, U.S. FDA, EU and international requirements.
  • Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.
  • Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.
  • Participate in audits and support field action teams.
  • Sponsor and actively monitor a high-performance management culture where employees have clear personal and business performance objectives.
  • Provide targeted career coaching and feedback; manage and develop team members at all levels of experience.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor's Degree
  • Minimum of 5 years experience in regulatory affairs for medical device with roles showing increasing responsibility
  • OR advanced degree and a minimum 3 years experience in regulatory affairs for medical device with roles showing increasing responsibility

Nice to Have (Preferred Qualifications)
  • Engineering or Advanced degree desired.
  • 3+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
  • Experience with Neurovascular medical devices
  • Proven track record of leading high performing teams
  • Ability to recognize and develop key talent
  • Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
  • Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines
  • Must work well in dynamic and cross functional team environments
  • Must demonstrate collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities
  • Proven analytical abilities and utilization of system tools such as electronic document control systems
  • Solid understanding of manufacturing and change control, and an awareness of regulatory trends
  • Understanding of engineering concepts and scientific terminology; experience with vascular therapies preferred
  • Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
  • Experience reviewing design specifications and other technical documents
  • Superior interpersonal skills
  • Excellent communication skills, both oral and written
  • Documented evidence of writing skills
  • RAPS certification (RAC)

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)

Posted: 2022-08-02 Expires: 2022-08-31
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