Employer: Page Group Salary: Date Added: 17/01/2024
Regulatory expertise for the EMEA region.
Significant contribution towards regulatory and quality systems compliance.
Client Details
Global Leader in IV Therapy remaining committed to bring clinically relevant products and technologies that help safely and efficiently meet patient care challenges.
Description
Provides regulatory advice and support to the business in relation to compliance, registration and conformity assessment of medical devices in the EMEA region.
Local regulatory contact for the EMEA Medical Device sales and marketing teams
Works to achieve department and company targets and goals.
Identifies and communicates registration needs to the global regulatory team and executes regulatory strategies to support new product launches and expansion of commercial activity.
Plans and organizes registration submissions to regulatory agencies and notified bodies. Prepares and maintains registration packages in line with European Union or EMEA international regulatory requirements and guidelines.
Evaluates product, process and labelling changes for regulatory impact.
Responsible for regulatory approval as part of sales enablement of product for EMEA distribution. Ensures products are authorised for release in compliance with company procedures and comply with regulatory requirements for the market.
Assist in the coordination of projects established to transition to compliance with the EU Medical Device Regulation (MDR) providing guidance on EU MDR requirements.
Maintains awareness of new and changing regulatory requirements.
Prepares monthly regulatory intelligence updates for the EMEA region.
Informs project teams of new and changing regulatory requirements and assists in assessment of impacts for the region.
Updates and maintains RA procedures as needed to ensure the company is in compliance with new and changing regulatory requirements.
Profile
Identify and communicate risks and critical points.
Analytically evaluate complex technical information
Effectively summarise and communicate complex issues/needs to peers, leadership and cross functional teams.
Able to implement department goals
Ability to influence and lead department members and peers and work effectively in teams.
Work to deadlines and identify urgent tasks.
Managing competing priorities effectively seeking input from supervisor as needed.
Job Offer
Opportunity to grow and develop your skill set & knowledge
