Job Description

Job Code: #10340
Title: Reg. Affairs Manager
Date Posted: 12/13/2018
Job Location: Malden MA

Job Description:

Regulatory Affairs Manager

We’re about hands-on, heads-down efforts, complemented by a company culture that fosters engagement. Collaboration drives our innovation, and we work with the best and the brightest in the business – movers and shakers who’re all hands on deck for success. As evolution happens, we revolutionize.

Position Overview

The Regulatory Affairs Manager will work as a member of the Quality and Regulatory group to ensure timely and successful regulatory submissions for US FDA, European MDD/ MDR, and MDSAP. This position will participate heavily with the Quality team to assure compliance, effectiveness, and maintenance of the quality management system and promote knowledge of regulatory requirements throughout the company. It will support reporting activities both within US and EU vigilance reporting. This position will serve as the RA representative on product development teams, facilitate compliance efforts across the organization. This position will be responsible for setup, management, and overall compliance of GUDID systems.

This is an opportunity for an experienced Regulatory Affairs Manager to apply their knowledge and clearly see the benefits realized from their individual contribution. This role also provides an opportunity for professional growth.

General Responsibilities

Manage EU MDD technical file, clinical evaluation reports, essential requirements

Planning and writing regulatory submissions/documents, including but not limited to:

Premarket notifications (510(k))

Premarket Applications (PMA) – original or supplements

Investigational Device Exemptions (IDE)

Design Dossiers, Renewals, Technical Files, Change Notifications, Letters to File

Providing regulatory assessments and input to product development teams

Defining efficient regulatory pathways and rationale

Communicating and negotiating with FDA personnel

Participating in risk management efforts with product development teams

Assessing and determining regulatory impact of proposed design changes

Documenting and appropriately communicating changes for cleared devices

Manage GUDID requirements and GTIN database

Specific Responsibilities

Manage EU MDD technical file, clinical evaluation reports, essential requirements

Planning and writing regulatory submissions/documents, including but not limited to

Premarket notifications (510(k)

Premarket Applications (PMA) – original or supplement

Investigational Device Exemptions (IDE) Design Dossiers

Providing regulatory assessments and input to product development teams

Defining efficient regulatory pathways and rationale

Communicating and negotiating with FDA personnel

Participating in risk management efforts with product development teams

Assessing and determining regulatory impact of proposed design changes

Documenting and appropriately communicating changes for cleared devices

Manage GUDID requirements and GTIN database

Required Competencies

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Position Requirements

The successful candidate will be required to possess:

7-10 years in a regulatory role in a medical device company, Spine preferred

B.S. in engineering or sciences or MS Regulatory

Experience writing successful regulatory submissions, especially 510(k),

Strong knowledge of the QSR, ISO 13485, EU MDD, GUDID, and MDSAP

Successful history serving as RA representative on product development teams

Ability to work in a fast paced and dynamic environment

Legally authorized to work in the United States on a regular full-time basis without restrictions

RAC Certification and European language capability desired, both a plus

Physical Requirements

This position operates in a mainly clerical setting. Routinely uses standard computer equipment, telephones, photocopiers, filing cabinets etc.

Sitting for extended periods of time using a computer keyboard and monitor

Frequently communicates with employees and vendors who have inquiries. Must be able to read, write and communicate to exchange accurate information in these situations.

Must be able to read, write and communicate fluently in English.

Required to have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.

Required to have close visual acuity to perform and analyzing data and figures, viewing a computer terminal; extensive reading at a distance that is close to the eyes.

Travel up to 10% and may include international travel


Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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