Job Details

Senior Regulatory Affairs Spec

Company name
Medtronic, Inc.

Location
Mansfield, MA

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Location:

Mansfield

MA

Date:

02/13/2018

2018-02-13

2018-03-14

Job Code:

40391

Categories:

Engineering

Marketing

Healthcare

Medtronic

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Job Details

Job Details

Company

Medtronic

Job Title

Senior Regulatory Affairs Spec

JobId

40391

Location:

Mansfield, MA, 02048, USA

Description

Senior Regulatory Affairs Spec

Location:

Mansfield, Massachusetts, United States

Requisition #:

17000M7M

Post Date:

2 days ago

**POSITION DESCRIPTION**

TheSenior Regulatory Affairs Manageris a working manager position responsible for obtaining worldwide product approvals to introduce new and modified medical device, pharmaceutical, and combination device products to the market. Drive pre and postmarket compliance activities. This position is responsible for implementing policies, procedures, and practices for Regulatory Affairs. Collaborate with RD, Clinical, Quality, regional Colleagues/Affiliates, and other required functions to develop and execute global regulatory strategies from product inception and throughout the product lifecycle. TheSenior Regulatory Affairs Managerdrives initiatives at the department or business unit level that focus on integration activities, process improvement, quality initiatives, or other efforts that leverage cross functional collaboration.

Directs and controls the activities of assigned team. Determines actual organizational structures and allocation of responsibilities. Provides leadership, coaching and career development for other members on the team. The working manager position may accomplish results through hands on and delegation of responsibility to individual contributors. Serves as a spokesperson for the team on highly significant matters. Interacts with leaders and executives to identify strategic initiatives and activities needed to drive business strategy.

**MAIN** **JOBDUTIES/RESPONSIBILITIES**

Responsible for the overall success of assigned team and integration into organizational segments.

Identify opportunities to meet customer and business needs. Clearly articulate a path forward even in highly ambiguous situations. Connect key data points, observe trends, and make the necessary trade offs to move the business forward. Appreciate, yet overcome complexity.

Develop global regulatory strategies for medical device, pharmaceutical, and combination product to meet business objectives.

Participate on Product Development teams, providing regulatory strategy, timelines, and direction. Review and approve design verification, design validation and stability protocols and reports.

Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.

Negotiate with regulatory authorities to resolve questions/issues that arise during submission review.

Drive product change assessments and define regulatory impact of product changes in global markets. Provide documentation to geographies that require a submission or amendment.

Review and approve labeling, training, promotional, and advertising material.

Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, and international requirements.

Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.

Interprets and executes policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.

Participate on audit and field action teams.

Sponsor and actively monitor a performance management culture where employees have clear performance expectations. Provide targeted coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly. Conduct timely and candid performance evaluations. Support meaningful development activities.

Lead efforts to attract, develop and retain individuals who can make critical contributions to organizational success.

**BASIC QUALIFICATIONS**

**EDUCATION REQUIRED**

Bachelor’s Degree in science, math or engineering discipline. Advanced degree desired

**YEARS OF EXPERIENCE**

10 years medical device industry experience with 7 years regulatory experience

3 years of experience providing leadership and managing functional teams.

**SKILLS AND COMPETANCIES**

Maintaining effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

Ability to work in an environment with delocalized teams and diverse cultures.

Good oral and written communication skills

Detail oriented and good program management skills

Proactive problem solving skills

**SPECIALIZED KNOWLEDGE REQUIRED**

Experience with pre and post market activities including, but not limited to, Investigational Device Exemptions, premarket notification applications [510(k)], premarket approvals [PMA], technical files, procedures packs, and design dossiers. Additionally, experience with evaluating change to existing commercially available products.

Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations. Combination product, tissues of animal origin, and/or pharmaceutical experience desired.

Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices as well as regulatory Compliance competency (e.g. Inspections, Audits, Field Actions).

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

Vascular access product experience desired.

**PHYSICAL JOB REQUIREMENTS**

Fast-paced office environment

Significant use of computer keyboard, monitor, and mouse.

10-20% travel, including international may be required.

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Company info

Medtronic, Inc.
Website : http://www.medtronic.com/

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.

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