Description
Regulatory Specialist - Country ManagerOur global medical device client is currently in the process of setting up a regulatory team in a new location. They are looking to recruit a talented and ambitious regulatory affairs specialist who has broad knowledge of regulatory submissions, variations and renewals to take on the role of country manager. This role is ideal for a professional who enjoys working in an international environment and is looking for an opportunity that provides excellent career progression.
Responsibilities:
The successful candidate will be working with regulatory documentation across the European and International Market for both drug and medical device products, and will have extensive interactions with the development process, internal teams, external customers and a variety of regulatory bodies.
• Maintain the drug files in compliance with regulatory standards.
• Coordinate and submit the yearly updates.
• Assist internal regulatory review processes for product life cycle and product development.
• Execute and improve internal records systems especially regulatory files.
• Support the evaluation of regulatory impact on current and new products.
• Act as safety officer in the post market surveillance process.
• Written and verbal interaction with relevant authorities or notified bodies.
• Assist the investigation and evaluation of regulatory history, guidelines, policies and regulation specific to products and markets.
• Provide regulatory input to product life cycle process including new product development processes, manufacturing, sales and customers.
• Assist in the development of regulatory strategy and update strategy based on regulatory changes.
• Act as a team member regulatory affairs to represent regulatory affairs on assigned product and project teams.
• Coordinate and moderate the Risk Management Process.
Skills:
Minimum:
• Experience in medical device and pharmaceutical industry essential.
• Knowledge of applicable international regulations and standards (MDD, ISO 13485, GMP).
• Experience of writing and reviewing modules 1-5 for drug/medical device submissions, variations and renewals.
• Broad understanding of the RA environment and interactions with related disciplines and customers.
• Excellent English language verbal and written
• Excellent Written and Verbal Communication Skills:
o ability to think strategically, exercise judgment and problem solve;
o ability to identify compliance risks and escalate as necessary;
o ability to work in a multi-functional team environment;
• Able to travel up to 25%