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Senior Regulatory Affairs Specialist (Remote)


Boulder, CO 80305
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Job Details

Senior Regulatory Affairs Specialist (Remote)


Boulder, Colorado, United States

Requisition #:


Post Date:

Dec 17, 2020


**Career That Change Lives**

The **Senior Regulatory Affairs Specialist** will engage with new product development (NPD) teams to establish regulatory strategies, participate in the creation and review of key product development deliverables, and author regulatory documents (e.g., 510(k), technical file). This role will support electrosurgical devices (e.g., generators, vessel sealing devices). As an NPD core team member, the senior specialist works directly with the NPD team from the concept phase through commercialization. The specialist has primary responsibility for compliance with U.S. and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. 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.

**A Day In The Life**

+ Define the regulatory strategy and manage regulatory submission activities for new technologies and product modifications, considering both domestic and international regulations

+ Provide regulatory affairs support to design teams and sustaining engineering; this includes input into bench and pre-clinical test requirements

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

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

+ Support international product registrations as needed

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

+ Evaluate information on competitive technologies as necessary to identify appropriate predicate or comparable devices to be included in 510(k)s

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

+ Review and approve marketing collateral

+ 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 of 4 years of medical device regulatory experience with Bachelors degree

+ Minimum of 2 years of medical device regulatory experience with an advanced degree


+ Experience authoring regulatory submissions (e.g., 510(k), EU Technical Files/Design Dossiers)

+ Degree in a scientific discipline

+ Working knowledge of IEC 60601-series standards

+ Prior experience with software-driven devices

+ Experience in Pre-Sub, 510(k), Technical Files/Design Dossier

+ Prior direct involvement with product development teams

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

+ Experience with 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

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

+ Advanced degree preferred

+ 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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