Vacancy Details

Manager of Regulatory Affairs


Regulatory Affairs Manager

Malden, MA, USA

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

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
  • 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:

* 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

Applying for the job

There are various ways to apply for this position:

  • Apply direct from the website (www.tecgroup.net) by clicking "apply now"
  • Contact the consultant directly:

Robert Pereira

About TEC Group International

We are TEC Group. We are international recruitment specialists. We are the link between highly-specialised industries and the professionals that make them work. Expert consultants, a global network of offices and the latest technology allow us to join the dots in the talent process.

TEC Group International supports the Scientific, Engineering and Energy sectors. We have completed assignments in over 60 countries and support projects all over the world through our subsidiaries and partners.

If you are applying via iPhone/iPad, please email your CV to vacancies@tecgroup.net