Principal Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Strategic Thinking, Leadership, Problem Solving, Technical Skills, Communication, Relationship Building, Clinical Development, Quality Systems, Medical Devices, Regulatory Submissions, Negotiation, Mentoring, Product Development, Change Control

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Develops domestic and international strategies for regulatory approval of new and modified medical devices. Supports international regulatory partners with commercial marketing applications and post-market studies Develops and maintains positive relationships with regulatory agency staff Bachelor's Degree, or the equivalent combination of education and experience required 7+ years of experience in Regulatory Affairs, or 5+ years of experience with an advanced degree (Master's or PhD) in a relevant scientific or engineering discipline Demonstrated leadership, strategic thinking, project planning, and project management skills Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing, and business strategies for global product commercialization Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, Pre-submissions, IDEs, 510(k)s, and MDR Technical Documentation Strong technical, research, and problem-solving skills Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Bachelor's Degree in life sciences, engineering, or related field Previous experience in the medical device industry with Class II or III device submissions Experience working directly with FDA, notified bodies, and/or international health authorities Able to work independently with minimal supervision Demonstrated ability to mentor junior regulatory staff members to aid in their development Able to work well in fast-paced cross-functional team environments Ability to articulate complex ideas clearly both verbally and in writing Demonstrated ability to develop strong relationships with regulatory agency staff Demonstrated ability to effectively lead multiple regulatory projects and priorities

Responsibilities

Develop domestic and international strategies for regulatory approval of medical devices. Support international regulatory partners with marketing applications and maintain relationships with regulatory agency staff.