Regulatory Project Manager

Description:

Full Job Description

This company is one of the largest global medical technology companies. They design, develop, and manufacture innovative and exciting minimally invasive medical devices.

In this role you will be working with the latest technologies across a large portfolio of products, you will work in cross functional teams as the regulatory medical device expert. This role offers a hybrid working model and flexi time. There is some local and international travel involved in the role.
For this role you will have a degree in engineering or science coupled with minimum 5 years' experience in a medical device industry ideally or a pharmaceutical background. Previous experience working in with regulatory submissions with knowledge and exposure to implantable devices desirable. Experience on EU MDR and ISO 13485, ISO 14971 is a must with knowledge of FDA and international regulatory requirements advantageous. Good knowledge in CE marking in line with the MDR also desirable. Strong team player with previous project management exposure.

Key Responsibilities

• • Ensures compliance with applicable Regulatory Requirements for all applicable territories in which devices are placed on the market.
  • Inputs to development of regulatory strategies and provides regulatory guidance and expertise.
  • Compiles and communicates regulatory requirements (e.g. MDR, FDA, International, standards, etc) to support R&D, Manufacturing & Quality to ensure systems are compliant with all internal and external guidelines.
  • Prepares and presents gap analysis assessments of regulations and guidance's to peers and cross-functional groups.
  • Reviews and approves the project documentation.
  • Develops tactics supporting regulatory notifications and submissions to minimize the market supply impact as a result of device changes.
  • Participates in product development/sustaining teams as required to ensure that the product follows all internal and external regulatory requirements.
  • Preparation and submission of dossiers to regulatory authorities for CE mark and FDA approval
  • Regulatory assessments of change requests and impact on global registrations
  • Provide support for regulatory authority and customer audits
  • Understand and follow company procedures on regulatory requirements.
  • Provide positive example and actively promote compliance to all standards.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Prepare and present project updates and technical discussions.
  • Requirement to travel to EU & USA to sites.