An opportunity has arisen to join a dynamic, independent developer and manufacturer of innovative and technologically advanced products for the global surgical and advanced wound care markets. Our products are sold in more than 70 countries via a network of multinational or regional partners and distributors, as well as via our own direct sales forces in the USA, U.K., Germany, the Czech Republic and Russia.
By leading a team at multiple sites, Job holder is responsible for defining and implementing regulatory strategy on Class I, Class IIa/IIb and Class III new product approval and day-to-day activities in compliance with applicable regulations. This position's responsibilities include tactical and strategic knowledge of EU medical device directives and regulations, ISO 13485 standards, good experience in managing Technical Files and Design Dossiers to successful approval. This position is reporting to Group QA/RA Director in UK, it is an office based role with flexibility working from home, and will require the individual to be available for travelling when required.
Essential Duties And Responsibilities
• By leading a regulatory team, job holder has the overall responsibility in regulatory affairs for multiple sites in UK and Germany.
• Plan and budget of regulatory resource and cost for UK & Germany sites
• Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations.
• Responsible for providing guidance on regulatory strategy to new product development and major extensions to existing product in getting regulatory approval within defined project timeline
• Support customer market registration activity, within the terms of existing contractual obligations.
• Undertaking and managing Technical File and Design Dossier audits/reviews by Notified Bodies. Liaising with or negotiating with regulatory authorities.
• Responsible for medical device vigilance and product recall according to applicable regulations or guidance.
• Participate in company quality system audits and co-ordinating the regulatory inspection when it is required.
Education And/or Experience
• A BS or MS degree in physical or life sciences required. An MBA, in addition to the technical degree, is a plus
• A minimum of 15 years regulatory affairs experience in the medical device industry in EU, must have knowledge of EU Medical Device Directive & new Medical Device Regulation, and hands-on experience in obtaining CE marking
• Strong leadership in managing a team from multiple sites, Jobholder must be able to demonstrate the ability to deliver to critical deadlines and manage staff’s workload and time effectively.
• Must have working knowledge on device-drug combination products
• Experience working across multi-disciplinary levels, functions and regions is required
• Good knowledge of European, USA, Canada, rest of the world medical Devices Regulatory requirements.
• Ability to do hands on work when required but having to influence the broader organisation