Senior Regulatory Affairs Specialist at Medtronic in San Antonio, Texas

Job Description:

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Senior Regulatory Affairs Specialist will play a key role in support of sustaining the Advanced Energy product portfolio. Sustaining regulatory responsibilities include reviewing product labeling for regulatory compliance, assessing and documenting decisions for device changes, reviewing new and modified regulations and guidance documents, ensuring accuracy of device technical documentation, and supporting regulatory compliance activities. The Senior 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., electrosurgical generators, vessel sealing devices). This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices.

Location: Remote from the U.S.

Responsibilities may 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.

Required Knowledge and Experience:

• Bachelors degree with 4+ years of regulatory affairs experience

OR

• An advanced degree with 2+ years of regulatory affairs experience

Nice to Have

• Previous experience with Medtronic


• Demonstrated history of successful regulatory submissions in the US and EU (510(k), EU MDR Technical Documentation) and pre-submission meetings


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


• Prior direct involvement with product development teams


• Experience with regulatory support of clinical trials for medical devices


• Working knowledge of IEC 60601-series standards


• Previous experience with software-driven devices


• Knowledge of MDSAP, ISO 13485, MDR audit requirements


• 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, EU Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$88,800.00 - $133,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.