Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Requirements

• 3 years minimum experience in a regulated industry.
• Bachelor’s degree in Scientific, Engineering, Regulatory, or core Life Science discipline. M.S. in a technical area or M.B.A. is preferred.
• Experience with successful preparation and submissions of Technical Documentation and/or global registrations of medical devices.
• Excellent understanding of international requirements (e.g. EU MDR) and experience expanding into multiple international regions such as MDSAP, APAC, MEA, LATAM, etc.
• Ability to manage multiple projects and/or competing priorities.
• Strong verbal and written communication and presentation skills, with the ability to speak and write clearly and convincingly in English.
• Strong organizational, analytical, and strategic thinking skills.
• Exercises good and ethical judgment within policy and regulations.
• A team player and collaborator with a service-oriented approach who is also flexible and proactive towards changing needs.

Responsibilities

• Build comprehensive regulatory submissions based on input from cross-functional teams and manage the execution of timelines and regulatory deliverables.
• Maintain regulatory submissions/renewals according to country registration requirements to facilitate product approvals on a global scale.
• Clearly and concisely communicate registration status and provide early visibility into risks/issues to enable timely action.
• Escalate registration risks, resource needs, priority conflicts, etc. to appropriate program and functional managers.
• Help lead regulatory discussions on country specific requirements and provide feedback to senior regulatory management.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
• Maintain current product registrations and assist in registration amendments when required.
• Help track advertising, promotional, and labeling materials and ensure timely delivery of marketing assets to international markets.
• Maintains a knowledge base in domestic and international regulatory policy, regulation and initiatives.
• Assisting and preparing the Regulatory department for both external authorities and internal audits.

Preferred Qualifications

• Experience in Artificial Intelligence/Machine Learning (AI/ML) or Software as a Medical Device (SaMD).
• Regulatory Affairs Certification (RAC).