International Regulatory Specialist- Maternity Cover

International Regulatory Specialist - Maternity Cover Position serves as a maternity cover for the International Regulatory Specialist role. Key Responsibilities Coordinate and support global product registrations and regulatory submissions for international markets Collaborate with Product Regulatory and Regional Regulatory Affairs teams to ensure timely and accurate submissions Maintain compliance with applicable regulations, standards, and internal procedures Support international audits and remain familiar with MDSAP requirements Work cross-functionally with Marketing, Sales, Supply Chain, R&D, and Quality teams to support product launches and market expansion Prepare, review, and coordinate submission documentation and registration requests Ensure regulatory deliverables are completed accurately and within deadlines Provide regulatory guidance to internal stakeholders regarding local and international requirements Monitor changes in regulatory legislation and communicate updates to relevant teams Support incident reporting, field actions, vigilance activities, and communications with regulatory authorities Maintain technical documentation and support post-market surveillance activities Participate in regulatory improvement initiatives and process optimization projects Support clinical and regulatory strategy activities related to new product approvals and portfolio development Qualifications 6+ years of Regulatory Affairs experience within the medical device industry Strong knowledge of international medical device regulations and standards Experience managing global registrations and regulatory submissions Familiarity with MDSAP and international regulatory requirements Experience working in cross-functional and international environments Strong communication, organization, and stakeholder management skills Ability to manage multiple projects and priorities in a fast-paced environment Proactive, detail-oriented, and solution-driven mindset Experience supporting audits, vigilance, post-market surveillance, and compliance activities Bachelor’s degree in Science, Engineering, Regulatory Affairs, Quality, or related field Fluency in English required Knowledge of international regulations in additional regions Previous supervisory or independent operational experience Project management experience in a global environment #J-18808-Ljbffr