Regulatory Affairs Specialist (M/F)

About Our Client

Our client is an international company noting a constant growth in its sector in the manufacturing market.

Job Description

• Provide support and guidance to analyze, design and develop regulatory files on various products and projects.
• Maintain on-going understanding and knowledge of the latest regulatory requirements in compliance with worldwide regulations and guidance documents. Key focus on European and US regulations.
• Review, preparation and implementation of regulatory SOPs, in line with both the applicable market requirements and best Group practices.
• Review regulatory documentation from key resources e.g. customers/projects, products etc. to ensure that customer and company requirements are met.
• Compilation/support the creation, of regulatory files, for key customers, products and projects.
• Provide input, at key project/design phases; e.g. pre-sales support, concept/design kick off, project/design review and final project/design transfer to production, to ensure that all regulatory requirements are 'in compliance'.
• Support validation activities, as necessary, to comply with defined regulatory regulations, global/local procedures and customer requirements.
• internal and external audits and any associated regulatory/quality assurance programs.
• Support, co-ordinate/conduct training in Regulatory procedures, as required.
• Support to the Quality Assurance Department for key operational activities e.g.;
• non-conformances/complaint reporting, where a regulatory issue is identified;
• specification approval,
• remotely support supporting internal and external audits based on approved schedule,
• update and correction of QMS documents and records archive (related to regulatory).

The Successful Applicant

• Bachelor's or advanced degree in engineering or a related major scientific discipline
• Minimum 3 years of experience in regulatory activities and associated requirements
• Experience within the regulatory industries associated with 21CFR820, ISO 13485, European regulations MDR, EUDAMED
• Previous experience in FDA and ISO regulated industries
• Experience in direct communication with Notified Bodies and Regulatory Agencies
• Ability to work independently or as part of a team to complete projects within required timeframes
• Highly proficient in spoken and written English

What's on Offer

• Ability to work in international environment both within internal organizational structure and customers (100% from Western Europe)
• Dynamic and fast growing culture company
• Continuous learning environment
• Opportunity for career progression dependent on achievements