25 days old

Regulatory Affairs Specialist - Diabetes

Medtronic
Northridge, CA 91325
  • Job Code
    2100086H

REGULATORY AFFAIRS SPECIALIST - DIABETES

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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 Live

The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce products and changes to market, provides advice on regulatory requirements, prepares submissions and negotiates their approval. The RA Specialist also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

A Day In The Life

  • Prepare international submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
  • Prepare regulatory strategies/plans and compliance requirements.
  • Provide on-going support to project teams for regulatory issues and questions.
  • Find, interpret and apply regulations and guidance appropriately for situations.
  • Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
  • Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation.
  • Prepare submissions and reports for regulatory agencies as required.
  • Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
  • Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
  • Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc.
  • Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
  • Work under general supervision following established procedures. Independently determines and develops approach.
  • Frequent inter-organizational contact and some external contacts.
  • Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
  • Provide training and support to other members of the department.
  • Other tasks, as required

Must Have (Minimum Requirements):

  • Bachelor's degree with a minimum 2 years of experience in regulatory affairs, medical device or quality, or advanced degree with 0 years of experience in regulatory affairs, medical device, or quality.

Nice To Have (Preferred Qualifications):
  • Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
  • 4+ years medical device industry experience
  • In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
  • Experience with Class III medical devices (PMA)
  • History of successful device submissions
  • Strong negotiation skills and written/oral communication skills
  • Strong organizational skills and time management skills
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
  • Ability to work independently and under general direction only
  • Computer skills; MS Office, MS Project, Adobe Acrobat and Agile

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)

Additional Information

  • Posting Date: Mar 24, 2021
  • Travel: No






Posted: 2021-03-26 Expires: 2021-04-24
Sponsored by:
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Sponsored by:
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Regulatory Affairs Specialist - Diabetes

Medtronic
Northridge, CA 91325

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