Job Description

Roles & Responsibilities
Support US and EU regulatory submissions, ensuring protection of proprietary information
Track regulatory timelines and document milestone achievements
Assess regulatory impact and contribute to regulatory strategy development
Review, collaborate on, and approve change requests and change notifications
Provide guidance to regulatory teams on:
New and renewal registrations
Product and process changes
Labeling content and compliance
Collaborate cross-functionally with internal teams
Perform additional duties as assigned by leadership
Experience Required
5-7 years of hands-on experience in Regulatory Affairs
Experience supporting medical devices (Class II and/or Class III)
Exposure to global regulatory submissions and compliance requirements
Skills & Certifications
Strong knowledge of US and EU regulatory frameworks
Understanding of global regulations for new products and product changes
Excellent written and verbal communication skills
Strong analytical, problem-solving, and critical-thinking abilities
High attention to detail and documentation accuracy
Ability to manage multiple priorities in a fast-paced environment
Proficient in Microsoft Word, Excel, and PowerPoint
Strong interpersonal and stakeholder management skills
Team-oriented with cross-functional collaboration experience
Eligibilities & qualifications
Bachelor's Degree or equivalent in a scientific discipline
(Biology, Microbiology, Chemistry, or related field)
Relevant regulatory coursework, seminars, or formal training preferred

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