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Senior Regulatory Affairs Program Manager


28 jours | Minneapolis, Minnesota, United States | Medtronic

Senior Regulatory Affairs Program Manager

28 jours | Minneapolis, Minnesota, United States | Medtronic


Date de début :août 22

Appliquer avant :septembre 22 2021

Industrie : Santé,

Type :Temps plein

Niveau d'ancienneté : 3-5 ans

Description du poste

SENIOR REGULATORY AFFAIRS PROGRAM MANAGER - Structural Heart & Aortic, Coronary & Renal Denervation and Cardiac Surgery Organizational Units

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.

Preference is for this position to be based in Mounds View, MN but can also be remote.

Careers That Change Lives

The Senior Regulatory Affairs Program Manager is responsible for leading, coordinating, and communicating the activities necessary for the Structural Heart & Aortic, Coronary & Renal Denervation, and Cardiac Surgery Organizational Units (OUs) to implement substantial new and/or changing regulations. The primary area of responsibilities for this role will initially be focused on implementation of the EU MDR/IVDR program, with a progressive transition of responsibilities into additional pan-Medtronic programs including UK Regulation Program, INFORM Regulatory Information Network Program, and Global Policy & Advocacy.

This position is accountable to leadership in Structural Heart & Aortic, Coronary & Renal Denervation, and Cardiac Surgery Operating Units and responsible for communicating project status to cross-functional and Corporate leadership.

A Day In The Life

  • Advise existing OU MDR project teams and functional representatives on EU MDR/IVDR requirements and lessons learned from ongoing review and advocacy activities with Notified Bodies and Competent Authorities.
  • Represent OUs as a member of the pan-Medtronic EU MDR Core Team Activities within this role include management of the collection and reporting on project status metrics, coordination of information/knowledge transfer to stakeholder & identification and escalation of business specific risks to senior leadership.
  • Collaborate with representatives from other Medtronic OUs to lead alignment on implementing EU MDR/IVDR requirements in shared quality system procedures and provide guidance to ensure EU MDR/IVDR requirements are strategically interpreted & implemented consistently across EU MDR/IVDR project teams.
  • Participate in Notified Body Coordination Group Meetings and, as needed, lead discussions with Notified Bodies on OU relevant topics (i.e. post market MDR/IVDR requirements, Medical Device Coordination Group document interpretations).
  • Supporting updates/communication to internal stakeholders of other relevant substantial regulation implementation programs (e.g. UKCA Mark, Swiss Device Ordinance, etc).
  • Transition into leading role responsible for coordination of communication and management efforts for new and changing requirements as part of the INFORM team. Collaborate and support other OU regulatory team members in execution of INFORM activities.
  • Transition into representative role for OUs at Global Advocacy and Policy Council monthly meetings, communicate related updates to OU RA leadership.

Must Have; Minimum Requirements

  • Bachelor’s degree
  • 7+ years of experience in regulatory affairs or the medical device industry with Bachelor’s degree OR
  • 5+ years of experience in regulatory affairs, or the medical device industry and an advanced
  • Experience working with medical device or pharmaceutical regulatory submissions

Nice To Have

  • Substantial knowledge of EU MDR and EU IVDR requirements / experience supporting Notified Body Tech Doc reviews / audits
  • 9+ years medical device industry experience
  • Project management skills
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
  • Effective interpersonal skills
  • Effective team member
  • Ability to effectively manage multiple projects and priorities
  • Experience utilizing collaborative IT systems (Teams, Sharepoint) to share information
  • Experience with Class II/III medical devices

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: benefits.medtronic.com

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: Aug 18, 2021
  • Travel: No

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