Sr. Regulatory Analyst - Oxenham Group : Job Details

The Sr. Analyst Regulatory Affairs is responsible for developing strategies to enable and maintain market access in the United States, Canada, Europe, and global regions, as well as managing medical device reporting related to the complaint handling process. In close partnership with Marketing, R&D, Clinical, Quality, Production, and Supply teams, the Sr. Analyst Regulatory Affairs will develop and advise on product licensing positioning, product maintenance, and exit strategies, among others. 2. Duties and Responsibilities

• Develops and updates US, global, regional, and multi-country licenses, aligning with organizational strategies and regulatory requirements.
• Provides guidance to integrate regulatory considerations into global product entry, maintenance, and exit strategies.
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures.
• Provides strategic input and technical guidance on global regulatory requirements to cross-functional teams.
• Offers guidance on regulatory strategies and submissions that address business, marketing, design, labeling, supply, and manufacturing changes.
• Ensures that submissions, product registrations, and related functions comply with international standards and government regulations, supporting our client's mission.
• Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
• Creates and submits documents and timely responses to international regulatory bodies, in accordance with local and international regulations.
• Represents regulatory licensing processes during internal and external audits.
• Participates in internal & external audits.
• Maintains a high level of team engagement.
• Manages and provides updates for regulatory metrics, implementing appropriate enhancements to regulatory processes.

3. Qualifications

• Bachelor's degree in a science, Bioengineering, or related field.
• Minimum of 5+ years of regulatory experience in the medical device industry, specifically with Class II and Class III products.
• Demonstrated knowledge and application of regulatory requirements, including ISO 13485, FDA, ISO 10993, MDSAP, EUMDR, and other international regulatory requirements under a regulated medical device quality management system.
• Technical knowledge of medical device products, including 510(k) submissions and the development of technical files.
• Strong written, verbal, listening, communication, and team-building skills.
• Ability to collaborate effectively with and lead cross-functional teams.
• Ability to prioritize and manage multiple project workloads effectively.
• Experience with trending and analysis reporting.