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Principal Regulatory Affairs Specialist (Remote)


Boulder, CO 80305
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Job Details

Principal Regulatory Affairs Specialist (Remote)


Boulder, Colorado, United States

Requisition #:


Post Date:

Dec 17, 2020


**Careers That Change Lives**

The **Principal Regulatory Affairs Specialist** will play a key role in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the concept phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for electrosurgical devices (e.g., generators, vessel sealing devices). Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting no file decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

**A Day in the Life**

+ Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations

+ Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions

+ Participate in negotiations and interactions with regulatory authorities during the development and review process

+ Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team

+ Support international product registrations as needed

+ Manage multiple projects and prioritize tasks on day by day basis to meet project schedules

+ Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities

+ Review promotional and advertising material

+ Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards

+ Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

+ Participate in internal and external audits as needed

+ Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements

+ Perform other duties as requested

**Must Have: Minimum Requirements (Must be evident on the resume):**

+ Bachelors degree

+ Minimum 7 years of medical deviceregulatory experience with Bachelors degree

+ Or minimum 5 years of medical device regulatory experience with an advanced degree

**Nice to Have:**

+ Demonstrated history of successful regulatory submissions in the US and EU

+ Advanced degree in a scientific discipline

+ Experience with regulatory support of clinical trials for medical devices

+ Working knowledge of IEC 60601-series standards

+ Previous experience with software-driven devices

+ Experience in Pre-Sub, IDE, 510(k), _De Novo_ , PMA, Technical File/Design Dossier

+ Prior direct involvement with product development teams

+ Strong interpersonal, analytical, writing, and organizational skills, including the ability to navigate the grey

+ Ability to analyze and resolve non-routine regulatory issues using independent judgment

+ Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

+ Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations

+ RAC credential preferred

**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.
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