Specialist II, Regulatory Affairs - Neuromodulation at Boston Scientific Corporation Malaysia

Heredia, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Data Integrity, Collaboration, Microsoft Teams, Audits, Post-Market Surveillance, Submissions, Technical Documentation, FDA Regulations, EU Regulations, Product Development, Excel Proficiency, Analytical Skills, Technical Writing, Quality Initiatives, Problem-Solving Skills

Industry

Medical Equipment Manufacturing

Description

Support RA systems, processes, and business process to improve the overall effectiveness of the Neuromodulation Regulatory Affairs function Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed Support efforts to improve collaboration, experience sharing, and best practices within the department and division Maintain regulated data for Neuromodulation using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc. Support regulatory information requests in support of audits, customs, post-market surveillance, government authorities, etc. Provide focused regional support and triage/monitor global registration requests Assist in the creation, maintenance, and tracking of submissions (i.e. 510(k), CE marking applications/change notices, technical documentation, requests for additional information, etc.) Act as a core team member on global project teams, providing Regulatory Affairs feedback and guidance Assist in monitoring and analyzing the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which products are regulated around the world Support and maintain Quality initiatives in accordance with BSC Quality Policy Continuously assess ways to improve Quality Bachelor's degree, preferably in a scientific or technical discipline. A minimum 2 years Regulatory Affairs or related experience, medical device industry experience preferred. Working knowledge of FDA and EU regulations for medical devices. General understanding of product development process and design control. English Level desired: 90% Ability to manage several projects High attention to detail, task oriented, deadline conscientious Proficiency in Excel with ability to convert data for more effective analysis Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel Effective research, analytical, and problem-solving skills Effective written and oral communication, technical writing, and editing skills Ability to work independently within defined parameters In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy Establishes and promotes a work environment that supports the Quality Policy and Quality System

Responsibilities

Support regulatory affairs systems and processes to enhance the effectiveness of the Neuromodulation Regulatory Affairs function. Assist in monitoring regulatory changes and provide support for submissions and audits.