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Sr Regulatory Affairs Specialist at Medtronic in Boulder, Colorado

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:

Sr. Regulatory Affairs Specialist

Careers that Change Lives

Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and support their global strategy for product launch. Provide strategic and operational support for global market access. Work closely with company partners as well as internal business team to facilitate optimal path to market. Participate in contracts and alliances for regulatory activities with various operational partners.

We're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.

Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

PATIENT MONITORING (PM) offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our device solutions that improve clinical outcomes.

A Day in the Life:

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

  • Build strategic plans for market access with internal and external stakeholders on a global scale and monitor plan execution.

  • Support customer focused regulatory activities and partner with different companies outside of Medtronic for customized devices.

  • Interact with internal marketing, R&D, QA, project managers as well as external Regulatory and Marketing partners.

  • Be an active contributor to the development of new products and provide support in regulatory strategies, registrations and approvals in different markets throughout the world.

  • Be responsible for specific regulatory document preparation, review and submission, and assist with compliance issues.

  • Build and maintain excellent relationships with representatives from corporate partners outside of Medtronic.

  • Interface with corporate partners through database portal (website).

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

  • Leads or compiles all materials required in submissions, license renewal and annual registrations.

  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

  • Monitors and improves tracking / control systems.

  • Keeps abreast of regulatory procedures and changes.

  • May direct interaction with regulatory agencies on defined matters.

  • Recommends strategies for earliest possible approvals of clinical trials applications.

    Must Have: Minimum Requirements

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

    Bachelor's degree with 4+ years of experience in regulatory affairs and/or regulated industry (medical device, pharma, biotech) OR Advanced degree with 2+ years of experience in regulatory affairs and/or regulated industry (medical device, pharma, biotech).

    Nice to Have (Preferred Qualifications)

  • Medical device experience preferred

  • Previous customer-facing and/or project management experience is desirable.

  • Previous experience working with global team is preferred.

  • Ability to comprehend principles of engineering, physiology and medical device use.

  • Experience with FDA and EU regulatory submissions and requirements.

  • Advanced degree in Business or MBA.

  • Working knowledge standard, guidance and regulations.

  • Prior experience using device software in a regulated environment.

  • Familiarity with regulatory requirements in major international markets.

  • Ability to effectively manage multiple projects and priorities.

  • Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.

  • Experience performing advertising and promotion reviews for medical devices.

  • Experience with international regulatory agency requirements.

  • Project management 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)

    Travel up 10% travel domestic and international

    Additional Information

    • Posting Date: Nov 25, 2020
    • Travel: Yes, < 25 % of the Time