The Regulatory Affairs Specialist will be responsible for ensuring that regulatory project deliverables (i.e. regulatory strategies, regulatory submissions, Regulatory Letters-to-File, review of project documents) are completed on-time for the various projects.
Project employee will support the following deliverables:
? Work in cooperation with personnel who maintain ultimate direction over the work.
? Support US, EU, and International regulatory affairs activities for various projects.
? Collaborate with cross-functional project team members and commercial partners to oversee the regulatory aspects of changes to products and process within the Wound Closure, Hernia, and Gynecology platforms to ensure products are in compliance with worldwide regulations and Directives.
? Prepare US, EU, and International Regulatory impact assessments for design, packaging, manufacturing, and labeling changes.
? Prepare submissions to US, EU, and International health authorities, as required.
? Submit notifications to Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc. and provide necessary documentation to country affiliates, where needed.
? Ensure all regulatory documents are complete, accurate, and well-maintained.
? Prepare regulatory labeling requirements specifications for new and modified products and review product labeling to ensure compliance, as required.
? Represent Regulatory Affairs on cross-functional project teams. Daily communication and meeting attendance with project teams, where needed.
? Daily or weekly communication with Regulatory Management on project status and deliverables.
Education & Experience Requirements:
? Minimum of a BA/BS within a technical related discipline is required.
? Minimum of 3 years of experience in Regulatory Affairs or a Master’s Degree with equivalent experience.
? Preference for medical device regulatory experience.
? Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes.