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Medtronic, Inc.

Senior Regulatory Affairs Specialist

Medtronic, Inc. - North Haven, CT

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Location:

North Haven

CT

Date:

12/02/2017

2017-12-02

2017-12-31

Job Code:

37174

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Legal

Marketing

Medtronic

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Job Details

Job Details

Company

Medtronic

Job Title

Senior Regulatory Affairs Specialist

JobId

37174

Location:

North Haven, CT, 06473, USA

Description

Senior Regulatory Affairs Specialist

Location:

North Haven, Connecticut, United States

Requisition #:

17000FPI

Post Date:

1 day ago

**SUMMARY OF POSITION** **:**

The Senior Regulatory Affairs Product/Operations Specialist can assist with preparation of U.S. FDA submissions, Design Dossiers for European Union submissions, Technical Files, reviewing design control documents and change requests, and being an active member of design teams representing the regulatory affairs responsibility.

The Senior Regulatory Affairs Product/Operations Specialist is responsible for communications and submissions to government agencies to support marketing approvals. This involves interfacing and supporting requests for information from government agencies. The position is also responsible for supporting Regulatory requirements within a Product Development process and working in a team environment with all organisational departments.

The Senior Regulatory Affairs Product/Operations Specialist is also responsible for overseeing international regulatory registration acitivity with the Regional Business Units (RBU).

**ESSENTIAL FUNCTIONS** **:**

Responsible for preparing the documentation and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements.

Prepare 510(k), Technical File, CE Mark, and other related regulatory filings.

IDE and PMA submission preparation as required

Collaborate with RD to determine and execute pre-clinical test plans in support of regulatory submissions.

Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies.

Provide regulatory affairs support to design teams and the document control/change request system.

Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the Company’s products.

Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.

Oversees the submission of International Registration Documents, progress reports, supplements and amendments.

Ensure the timely and accurate filing of regulatory documentation.

Develop and maintain product technical files.

Review and approve Marketing Collateral in support of product commercialization activities.

Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.

Participate in compliance activities that relate to the department and the company as a whole.

Perform other regulatory affairs duties when requested.

May have to travel internationally.

**DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:**

Other duties as assigned with or without accommodation.

**MINIMUM REQUIREMENTS** **:**

**Education:**

Bachelors Degree in scientific discipline, Masters Degree and RAC credential preferred

**Experience**

Minimum 5 years of experience in Regulatory Affairs arena

**Preferred Skills/Experience**

Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices are a plus

Demonstrated experience with submission to the European Union

Excellent written and oral communication skills

Computer literacy, proficiency in MS Word, Excel, PowerPoint, etc

Excellent organizational and multi-project management skills and attention to detail

**Skills/Competencies**

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.

**Additional Skills**

Multi-tasks and prioritizes effectively in fast-paced environment

Highly organized, detail oriented, and efficient.

Highly self-motivatedTeam 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

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.

**ORGANIZATIONAL RELATIONSHIPS/SCOPE** **:**

Works directly with the Director and/or Manager of Regulatory affairs on FDA and other Regulatory Affairs matters when required.

Works with supervisors and managers 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 regarding status of regulatory submissions and other regulatory matters

**ABOUT MEDTRONIC:**

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.

**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.

**EEO STATEMENT:**

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 at http://www.uscis.gov/e-verify/employees :// at http://www.uscis.gov/e-verify/employees www.uscis.gov/e-verify/employees

**DISCLAIMER:**

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.

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8 days 13 hours ago

Medtronic, Inc.

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Senior Regulatory Affairs Specialist Medtronic, Inc. - North Haven, CT, United States

   

Location: North Haven, CT

Company Profile:
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.