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Principal Regulatory Affairs Specialist

North Haven, CT
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  • Job Code
Company Medtronic
Job Title Principal Regulatory Affairs Specialist
JobId 34008
Location: North Haven, CT, 06473, USA

Principal Regulatory Affairs Specialist


North Haven, Connecticut, United States

Requisition #:


Post Date:

Oct 27, 2017

**Principal Regulatory Affairs Specialist**

**Careers That Change Lives**

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.

**MITG's SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

As **Principal Regulatory Affairs Specialist** ,you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.

Come strengthen your specialized skills and enhance your expertise. We’ll help you to expand your expertise with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you. Together, we can confront the challenges that will change the face of healthcare.

You must have a track-record of building strong teams and developing innovative regulatory strategies for novel, Class III products. Global combination device experience would be beneficial.

**A Day in the Life**

The **Regulatory Affairs Program Manager** is responsible for developing strategies for worldwide regulatory approval to introduce new products to market and preparing U.S. submissions. Provides support for major market regulatory approvals and post-market support of market-released products. Ensures compliance with Medtronic, FDA and International requirements.Your focus will be:

+ Prepare U.S. submissions and International submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review complex product submissions with manager or other senior management and negotiate submission issues with agency personnel.

+ Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions.

+ Provide business and product information to international regulatory managers to enable development of worldwide strategies and requirements, and communicate that information to business teams. Provide product and test information to major markets to support their local regulatory submissions.

+ Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval. Prepare submissions and reports for FDA and support other major market regulatory agencies as required by product status.

+ Negotiate directly with FDA on projects/products at reviewer level. All significant issues will be reviewed with the manager and/or other senior management.

+ Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with Regulatory Body personnel.

+ Maintain Regulatory Affairs product files to support compliance with regulatory requirements.

**Must Have: Minimum Requirements**

+ Bachelor’s Degree in science, math or engineering discipline.

+ Minimum 9 years medical device industry experience with 5 years regulatory experience. (Or advanced degree with 7 years industry experience.)

+ Class I, II, III device experience and in-depth knowledge of FDA medical device regulations.

+ History of successful 510(k)/IDE/PMA device submissions and experience with regulatory support of clinical trials. Knowledge of GLP/GCP requirements and excellent negotiation kills and written/oral communication skills.

+ Knowledge of QA system requirements: QSR and ISO 13485, MDD requirements including Device Experience Reporting.

+ Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices.

+ Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003

**Nice to Have**

+ Advanced Degree.

+ R.A.C certification(s).

+ Regulatory Compliance competency (Inspections, Audits, Field Actions, Quality Systems …)

+ International Regulatory competency.

+ Clinical Trial experience.

+ Proficiency in FDA compliance.


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. 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.


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.

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:

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.


  • Engineering
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  • Manufacturing / Production
  • Healthcare
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North Haven, CT

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