Regulatory Affairs Specialist

Job Purpose

The Sr. Analyst Regulatory Affairs is responsible for developing to enable and maintain market access the United States, Canada, Europe and global regions. As well as the medical device reporting related to the complaint handling process.

Through close partnership with Marketing, R&D, Clinical, Quality, production and supply teams, the Sr. Analyst Regulatory Affairs will develops and advises on product licensing positioning, product maintenance and exit strategies, among others.

Duties and Responsibilities

• Develops and updates US, global, regional and multi-country licenses, and in alignment to organizational strategies regulatory strategies
• 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.
• Provides guidance on regulatory strategies and submissions addressing business, marketing, design, labeling, labeling, supply and manufacturing changes
• Ensure that submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission.
• Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.
• Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
• Create and submit documents and timely responses with international Regulatory bodies, in accordance with local and international regulations.
• Represent regulatory licensing processes during internal and external audits
• Participate in internal & external audits.
• Maintain a high level of team engagement
• Manage and provide updates for regulatory metrics. Implement appropriate enhancements to the regulatory processes.

Qualifications

• Bachelors in a science, Bioengineering degree, or related Advanced degree related to Bioscience.
• Minimum of 5 years of regulatory experience working in the medical device industry specially with Class II and Class III products.
• Demonstrated knowledge and application of regulatory requirements, including ISO 13485, FDA, ISO 10993, MDSAP, EUMDR and others international regulatory requirements under a regulated medical device quality management system.
• Demonstrate technical knowledge of medical device products including 510Ks submission and the development of technical files.
• Demonstrated written, verbal, listening, communication, and team-building skills
• Demonstrated ability to collaborate effectively with and lead cross-functional teams
• Demonstrated ability to effectively prioritize and manage multiple project workloads
• Demonstrated experience with trending and analysis reporting