🌎
This job posting isn't available in all website languages

Sr Regulatory Affairs Specialist - Globalization

📁
Regulatory Affairs
📅
20000BIB Requisition #
SENIOR REGULATORY AFFAIRS SPECIALIST - GLOBALIZATION
Sunnyvale, CA

The Gastrointestinal and Hepatology (GIH) business offers technologies to help with early detection and treatment of gastrointestinal diseases and cancers, and focuses on reducing complications through patient monitoring.

 

Careers That Change Lives  

The Senior Regulatory Affairs Specialist is responsible for developing and executing strategies for worldwide governmental approval to introduce new products (Class II & III) and maintain existing products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies.  In addition, this position also assists with the mentoring and training of other regulatory affairs associates including providing work direction on projects of large scale with significant business impact.  

 

A Day in the Life / Responsibilities:

 
  • Partner with business unit Regulatory Affair Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  •  Prepare submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and work on  submission with regional counterparts.
  •  Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for international agencies as required by product status.
  •  Interact directly and/or indirectly with international regulatory agencies on most projects/products at reviewer level. Review significant submission decisions/content issues with manager.
  •  Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
  •  Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with international agency personnel and business units.
  •  Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams. 
  •  Provide feedback and on-going support to product development teams for international regulatory issues and questions.
  •  Ensure personal understanding of all quality policy/system items that are personally applicable.  Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • May mentor or supervise other RAS, as directed by manager. 

 

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

  • 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
Bachelor’s degree with 4+ years of experience in regulatory affairs and/or the medical device industry OR Advanced degree with 2+ years of experience in regulatory affairs and/or the medical device industry.

 

Nice To Have:

  • 5+ years medical device industry experience

  • Experience with Class II/III medical devices

  • Experience with medical device global product registrations/ submissions: US FDA 510(k)s/ PMAs, EU Tech Files, Health Canada license applications, Shonin (Japan PMDA), China NMPA, APAC and Latin America submissions.

  • Experience performing advertising and promotion reviews for medical devices

  • Medtronic product development experience

  • Clinical or statistical experience

  • Experience with international regulatory agency requirements, harmonized IEC/ISO/ GHTF standards.

  • Strong communication and project management skills

  • Effective interpersonal skills to be a good team member and mentor

  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

  • Ability to effectively manage multiple projects and priorities.

  • Proficient computer skills 

                       
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 to 20% domestic & international

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

Be part of work that matters. 75 million patients had their health improved by our products last year.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.