International Regulatory Affairs Manager – Job Vacancies In Convatec Valley

Overview

Position Title: International Regulatory Affairs Manager

Company: Convatec

Location: Valley, UK

Job Description

ConvaTec is a global business providing medical devices to patients across the globe. As we expand our current portfolio and increase our current Advanced Technology field, we are looking for an experienced Regulatory Manager for International Regulatory Affairs. This role will act as a bridge between our international regulatory group and the ‘core’ regulatory team. The role will include coordination of regulatory submissions and development of appropriate documentation and systems in conjunction with both regulatory groups. The successful applicant will be integral in the development of international strategy and will interact daily with our global regulatory team.

Responsibilities:

• The successful applicant will manage a small team as well as interacting with the global regulatory organisation (LATAM, APAC, EMEA) in a matrix like structure providing guidance for the international regulatory team on ongoing projects and corporate initiatives.
• You’ll be key in providing details of the international arm of the company regarding strategy and commercial needs to the regulatory and technical groups within the company.
• Liaising with a broad range of domestic groups across the business in relation to any changes to project scope, timelines, regulations etc.
• Gathering all documentation for new submissions and ensuring high attention to detail when dealing with international country requirements.

Requirements:

• Demonstrable submission history experience for US, EU and international as well as knowledge of international submission processes, language skills are also a plus.
• Regulatory degree, while not a requirement, would be an advantage.
• A number of years’ experience within the Medical Device field