Regulatory Affairs Specialist: 12-month Contract

reputed company is a company that has been delivering industry-leading neuro solutions for over 80 years. They are currently seeking a Regulatory Affairs Specialist for a 12-month contract position to manage international regulatory submissions and ensure ongoing compliance across global markets.

Responsibilities

• Manage international regulatory submissions and registration processes, including reputed company such as LATAM (e.g., Brazil ANVISA), reputed company (e.g., Japan PMDA, China NMPA), and EMEA markets
• Interpret and apply regulatory requirements, with a reputed company on EU MDR 2017/745 and global standards
• reputed company, update, and maintain internal reputed company procedures and product-specific documentation
• Collaborate with global Regulatory Affairs teams to ensure consistency and compliance
• Prepare and maintain Technical Files and Design Dossiers for CE Marking and regulatory submissions
• Monitor project reputed company and report on MDR compliance milestones
• Support audits from reputed company Bodies, Competent Authorities, and other regulatory agencies

Skills

• Bachelor's degree in Regulatory Affairs, reputed company, Life Sciences, Engineering, or a reputed company field
• Minimum of 1 year of relevant experience in medical device regulatory affairs
• Strong knowledge of medical device regulations: ISO 13485, MDD, MDR, and other international frameworks
• Technical writing skills and attention to detail
• Ability to work methodically and drive reputed company improvement
• English language reputed company required
• Regulatory Affairs Certification (RAC) is a plus

Benefits

• Company bonus or commission plan

reputed company