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Sr Regulatory Affairs Specialist

Boulder, CO 80305
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Sr Regulatory Affairs Specialist


Carlsbad, California, United States

Requisition #:


Post Date:

Sep 09, 2020

**Sr Regulatory Affairs Specialist**

**Boulder, CO or Carlsbad, CA**

**Careers that Change Lives**

The Sr Regulatory Affairs Specialist is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for submission activities focused on US/EU and for ensuring regulatory compliance.This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs.Collaborate with International RA, RD, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

RESPIRATORY, GASTROINTESTINAL INFORMATICS (RGI) 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 therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.

This is a cross-functional, collaborative operating unit to employ 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.

**A Day in the Life**

+ Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products.

+ Participate on Product Development teams, providing regulatory strategies, timelines, and direction.Reviews and approves technical documentation.

+ Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.

+ Drive product change assessments and define regulatory impact of product changes in global markets.

+ Review and approve labeling, training, promotional, and advertising material.

+ Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, EU MDR and international requirements.

+ Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, issue assessment).

Responsibilities may alsoinclude 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**

Bachelors degree with 4+ years of experience in regulatory affairs and/or medical device OR Advanced degree with 2+ years of experience in regulatory affairs and/or medical devices.

**Nice To Have**

+ Engineering or Advanced degree desired.

+ Excellent knowledge of U.S. and European/International regulations and standards

+ Experience interacting with FDA and/or other regulatory agencies

+ Previous experience in EU MDR

+ 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

+ Proven analytical abilities

+ Solid understanding of manufacturing and change control, and an awareness of regulatory trends

+ Understanding of engineering concepts and scientific terminology

+ 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

+ Basic understanding of computer applications; proficient in Microsoft Office Applications

+ Familiarity with medical terminology

**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. Lets 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)

Must be able to travel by plane and by car (10 - 20%), including International travel.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-06-26 Expires: 2020-10-19
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