Integra LifeSciences

Regulatory Affairs Project Manager

Vacancy ID
2017-24422
IE-Tullamore
Position Type
Regular Full-Time
Category
Regulatory Affairs

Overview

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.

 

Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, tissue reconstruction and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

 

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

The main responsibilities of the position are:

 

  • Manage the products’ registrations in Europe Middle East and Africa area (EMEA) for the portfolio defined by the EMEA RA Manager and the VP RA International.

 

 

  • Manage the customers’ complaints for your products’ portfolio in synergy with the EMEA Quality and Compliance Teams.

 

 

  • Pre-reviewed the promotional materials issued by the EMEA Marketing team in compliance with the EMEA local regulations (i.e Bertrand’s Law) and the INTEGRA’s rules.

 

 

  • Make an active Regulatory Intelligence on the countries regulations and specific topics defined by EMEA RA Manager and the VP RA International.

 

 

 

Qualifications

RA Skills

  • Knowledge on the European Medical Devices Directive 93/42/EEC and its relatives
  • Project Management Skills
  • Experience in International and/or European products’ registrations
  • Experience in customers complaints handling

Schooling Level 

  • Pharmacist / Sciences Doctorate / Biomedical Engineer/ Master in Regulatory or Quality

Professional Background 

  • 3 to 4 years experiences in Regulatory Affairs in Pharmaceutical or Medical Devices industry

Personal Qualities

  • Organizational skills
  • Autonomous
  • Writing skills
  • Interpersonal skills

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