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Sr Regulatory Affairs Specialist - Patient Monitoring

Boulder, CO 80305
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Sr Regulatory Affairs Specialist - Patient Monitoring


Boulder, Colorado, United States

Requisition #:


Post Date:

Aug 18, 2020

**Sr Regulatory Affairs Specialist**


**Boulder, CO**

**Careers That Change Lives**

**This position is in the Patient Monitoring (PM) Regulatory Affairs team, one of the three divisions of Respiratory, Gastrointestinal Informatics (RGI). The Sr. Regulatory Affairs Specialist will engage with cross-functional teams to establish regulatory strategies, participate in creation and review of key product development deliverables and author regulatory documents (510(k)s and EU Technical Documents).** **Provide support for currently-marketed products, including review of product/ manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.**


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.

**A Day in the Life**

+ **Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.**

+ **Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs 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 regulatory (eg, FDA/Notified Body) 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 negotiate submission issues with agency personnel.**

+ **Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.**

+ **Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.**

+ **Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.**

+ **Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.**

+ **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 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.**

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**

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

Bachelors Degree with 4+ years or Regulatory Affairs experience in the medical device industry OR Advanced Degree with 2+ years of Regulatory Affairs experience in medical device industry.

**Nice to Have (Preferred Qualifications)**

+ 4+ year regulatory submission experience

+ Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).

+ Experience working with medical device or pharmaceutical regulatory submissions

+ Working knowledge of IEC 60601-series standards

+ Product experience with Radio Equipment Directive (RE-D)

+ Prior experience with software-driven devices or Software as Medical devices (SaMD).

+ Familiarity with regulatory requirements in major international markets

+ Experience with EU- MDR

+ 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.

+ 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 FDA and international regulatory agency requirements

+ Project management skills.

+ Excellent oral and written skills.

+ Excellent analytical thinking 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. 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)
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: 2020-08-21 Expires: 2020-09-27
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Boulder, CO 80305

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