Join AxioMed & SpineFrontier as Associate Manager, Regulatory Affairs

Join AxioMed & SpineFrontier as Associate Manager, Regulatory Affairs
Join AxioMed & SpineFrontier as Associate Manager, Regulatory Affairs

19 December, 2017

Position Overview

This is a joint position shared between AxioMed and sister company SpineFrontier but with majority of work on AxioMed to start.

The Regulatory Associate 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 associate 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 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

 

Required Competencies:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.

 

Position Requirements

The successful candidate will be required to possess:

  • 5 years in a regulatory role in a medical device company, Spine preferred
  • S. in engineering or sciences or MS Regulatory or combined education and experience equivalency
  • 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 equipment, telephones, photocopiers, filing cabinets etc.
  • Position requires sitting for extended periods using a computer keyboard and monitor.
  • Routinely needs to do filing, which will require opening file cabinet drawers, being able to bend for file placement.
  • The position frequently requires objects to move from one place to another under 5 pounds lifting is periodically needed in order to move files.
  • This person frequently communicates with employees and vendors who inquire and must be able to read, write and communicate clearly to exchange accurate information in these situations.
  • Worker is required to have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
  • Worker is required to have close visual acuity to perform and analyzing data and figures, viewing a computer terminal; extensive reading at a distance close to the eyes.
  • Must be able to read, write and communicate fluently in English

 

Environmental Factors 

Work is generally performed within an office environment, with standard office equipment available.  Travel up to 10%.

 

Location

Malden, MA

 

How to Apply

We offer tremendous room for advancement and income potential. All submissions will be held in the strictest confidence. This position is being sought after for immediate hire. The company is an Equal Opportunity Employer. Please submit your resume and cover letter to Mycareer@axiomed.com

 

SpineFrontier

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