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 us. (West) 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 Wests 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 West regulations, practices, and procedures to maintain compliance.
Requirements: Basic Qualifications:
Bachelor's Degree- in science, math, engineering, or related discipline- required.
Master's Degree- in science, math, engineering, or related discipline- an advantage.
PhD- in science, math, engineering, or related discipline- an advantage.
Preferred Knowledge, languages, Skills and Abilities:
Bilingual - English and Hebrew.
Advanced knowledge of 21 CFR 820/ISO 13485.
Advanced knowledge of product life cycle, product development process, design control and change control and 21 CFR 820/ISO 13485.
Possesses technical leadership skills, as well as demonstrated understanding of related medical device operations (e.g., Design History File (DHF) maintenance, manufacturing, process development, analytical, quality assurance).
Excellent oral communication, technical writing, and decision-making skills.
Self-motivated with a proactive attitude and the ability to work effectively.
Regulatory compliance and International competency including Quality Systems.
Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
Excellent oral communication and technical writing skills.
This position is open to all candidates.