The company
Medella Life is working with a global top 10 life science company who are specialise in providing and delivering innovative health solutions for over 130 years to prevent diseases in both humans and animals. They are now in the process of expanding their regulatory team and are seeking a Regulatory Subject Matter US Lead to join them!
The role
Regulatory Subject Matter US Lead manages US team reporting direct to the Head of Regulatory Affairs. Under your supervision will be Subject Matter Experts working on the assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products in new territories ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.
Responsibilities:
Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals (removed device master records)
Maintain library/database of technical documentation
Monitor the status of standards and regulations. Conduct a review and analysis in case if requested. Assist and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations.
Review updated documentation requirements and carry out documented review, ensuring any necessary updates are made; disseminate relevant information throughout the site
Manage regulatory review for CAPA investigations, adverse events, validations, and general projects (removed printed materials & added adverse events)
Support preparation of and participate in all customer audits which require regulatory input
Support preparation for and participate in audits by regulatory bodies
Manage regulatory review for labeling materials including labels, instructions for use, package inserts, advertising/promotions, and websites
Support new product development projects which require regulatory input
Analyze new registration requirements to determine impact to the business and/or site and document as necessary
Respond to internal and external customer regulatory requests and/or inquiries
Support any recall or notification actions and carry out regulatory vigilance reporting as required
Act as liaison between site and internal and external in country representatives
Maintain records of registration activities and license changes utilizing Good Documentation Practices
Requirement
Bachelor's degree required, prefer Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline
3+ years of personal management experience
3+ years of professional experience in Regulatory Affairs (IVD)
Depth and breadth of expertise combined with in-depth knowledge of market, competitors, and authority landscape
Experience with in-vitro diagnostics
Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Excellent organizational, prioritization, and problem-solving skills
Excellent project management skills
Ability to work independently and effectively manage multiple tasks/projects with varying deadlines and requirements
Proficient in MS Office Software (Word, Excel, PowerPoint)
Excellent technical and report writing skills
Ability to effectively work both in a team situation and individually with minimal supervision
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything