Regulatory Affairs Specialist EMEA

Job description

Primary Function of Position

The Regulatory Affairs Specialist plays an important role within the Regulatory Affairs Department, focusing on providing advanced regulatory support for New Product Development (NPD), market expansion and sustaining operations across designated Business Units. This position requires advanced understanding of EU and global medical device regulations, and experience in managing regulatory submissions and compliance activities.

The Regulatory Affairs Specialist collaborates with cross-functional teams, offering guidance on regulatory matters, while contributing to the success of product launches and ongoing operations.

Roles and Responsibilities

Assess regulatory impact within EMEA (EU/EEA, Middle East, Africa) and support implementation of new markets, product expansion in existing markets, and new product introduction. Provide guidance to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements. Manage the preparation, submission, and maintenance of EMEA medical device registration dossiers, ensuring compliance with local regulations, timely regulatory approvals, and up-to-date records.

Coordinate registration strategy with cross-functional partners such as Product Lifecycle Management, Supply Chain, Marketing, and Commercial teams, aligning regulatory requirements with business objectives. Prepare and review regulatory correspondence, Letters of Notification, declarations, certificates, and supporting technical documentation. Monitor and perform sustaining activities including renewals, amendments, and change notifications for assigned markets.

Perform regulatory impact assessments for changes throughout the product lifecycle such as design modifications, labeling updates, software releases, etc. Maintain registration trackers, regulatory databases, and product registration records. Monitor and evaluate changes in medical device regulations and standards for assigned markets, updating departmental policies and procedures as necessary to maintain compliance. Coordinate and support responses to regulatory authority inquiries and requests for additional information relevant to team activities.

Support audits, inspections, and compliance activities as needed. Address regulatory inquiries from cross-functional partners for assigned markets, providing timely and accurate information. Identify opportunities and participate in projects to improve efficiency, compliance, and process standardization. Perform other regulatory tasks and projects as assigned, ensuring regulatory compliance across regional markets.

Qualifications

Required Knowledge, Skills, and Experience

Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly preferred, though practical experience in a similar role will be considered. Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms. 5+ years of experience in regulatory affairs within the medical device industry, with experience or exposure in the following areas: Medical device registration lifecycle management, including new registrations, renewals, amendments and change management.

Regulatory impact assessments and change notification strategies. Advanced understanding of Global regulatory requirements and standards for Medical Devices relevant to product compliance (e.g., EU MDR 2017/745, ISO 13485, RoHS, etc.). Detail-oriented with strong project management and organizational skills. Ability to lead resolutions across international teams to effectively address project risks. Proactive approach to problem-solving, and collaborative/supportive in team setting.