This job posting isn't available in all website languages

Set Job Alert

Associate Regulatory Prooduct and Operations Specialist

Regulatory Affairs
170003ZY Requisition #
Thanks for your interest in the Associate Regulatory Prooduct and Operations Specialist position. Unfortunately this position has been closed but you can search our 2,749 open jobs by clicking here.


Education required:

-        Bachelor’s degree in a scientific or engineering field

-        Bachelor’s degree in any field and 2 years of experience in a Medical Device or similar regulated industry


-        0 – 2 years related experience in a technical job function/role, depending on degree type.

Preferred Skills/Qualifications:

-        Experience in a regulated industry, preferably medical devices, with an emphasis in regulatory or quality assurance

-        Excellent verbal and written communication skills

-        Experience using ERP software (BPCS/SAP preferred), electronic filing systems,  and/or databases

-        Ability to interface effectively with individuals from a wide variety of disciplines to research and obtain appropriate documentation for the submission of regulatory information.

-        Ability to prepare and submit regulatory documentation packages.


-        High Level of proficiency using MS Excel and MS Word.

-        Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro.

-        High learning aptitude and adaptability with software systems

-        Demonstrated technical writing skills.


Other Skills:

-        Multi-tasks and prioritizes effectively in fast-paced environment

-        Highly organized, detail oriented, and efficient.

-        Highly self-motivated

-        Team player who seeks to help and learn from colleagues seeing the department success as their own

-        A problem solver and critical thinker that relies on own judgment for appropriate level of decision making

-        Demonstrated leadership qualities

-        Ability to manage small scale projects to completion within and outside of the direct department.

-        Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

-        Proactively seeks to develop and become well-versed within in the regulatory landscape.


-        Reports to a Manager of Regulatory Affairs

-        Works directly with the Director and/or Manager of Regulatory affairs on FDA and European, and international regulatory matters when required.

-        Works with supervisors and managers outside of RA during the course of registration preparation.

-        Works with state personnel and foreign consulates/embassies personnel as appropriate.

-        Works with project team members and other company personnel as required.

-        Communicates with FDA,  European Notified Body, and international regulatory counterparts regarding status of regulatory submissions and other regulatory matters


-        Telephone, personal computer, copy machine, scanner and facsimile machine

-        Usual office environment with frequent* sitting, walking, and standing, and occasional* climbing, stooping, kneeling, crouching, and balancing.

-        Position requires less than 10% travel.

-        Ability to move from department to department and building to building to attend meetings, conduct audits, and perform product investigations.

-        Frequent* use of eye, hand, and finger coordination enabling the use of office machinery.

*Occasional:         Activity exists less than 1/3 of the time.

*Frequent:             Activity exists between 1/3 and 2/3 of the time.


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 


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.


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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.



My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

North Haven, Connecticut, United States

📁 Regulatory Affairs

Requisition #: 170003ZY

North Haven, Connecticut, United States

📁 Regulatory Affairs

Requisition #: 170008XH

Woburn, Massachusetts, United States

📁 Regulatory Affairs

Requisition #: 16000DRA

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.


The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More


Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More


Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More


Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More


Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


Be part of one of the world’s leading medical technologies and solutions companies.