SR. RA Specialist

The Regulatory Affairs Sr. Specialist is expected to perform with minimal support and is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with our Services, Inc. and applicable regulatory requirements. This position includes supporting internal and external customer regulatory requests.
Essential Duties and Responsibilities:
Develop and implement medical device regulatory strategies for our Administration and Safety Systems portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner
Author and review US, EU, Japan, China, and additional international submissions with guidance for new products and product changes as required to ensure timely approvals for market release
Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
Provide support to market-released products as necessary, including reviewing manufacturing process changes and documentation for changes requiring regulatory approval
Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products
Create documentation in response to customer and regulatory agency requests, including regulatory letters, technical packages, etc.
Write or update standard operating procedures, work instructions, or policies
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
Adhere to all applicable government and our regulations, practices, and procedures to maintain compliance