Our client is a pioneering force in the medical device industry, committed to advancing healthcare solutions. We are currently seeking a Senior Manager of Regulatory Affairs to join our team in Massachusetts, contributing to our mission of delivering innovative, high-quality medical devices.🧠🔍
Regulatory Strategy: Develop and implement effective regulatory strategies for product submissions and approvals.
Compliance Oversight: Ensure adherence to global regulatory requirements, including FDA, ISO, and other relevant standards.
Cross-functional Collaboration: Collaborate with product development, quality assurance, and other teams to integrate regulatory considerations into project plans.
Submission Management: Prepare, submit, and manage regulatory filings and applications for product approvals.
Regulatory Intelligence: Stay informed about changes in regulations and industry trends, providing guidance to internal stakeholders.
Audit Readiness: Ensure the organization is prepared for regulatory inspections and audits, maintaining documentation compliance.
Labelling and Promotion: Review and approve labelling and promotional materials to ensure regulatory compliance.
Bachelor's degree in a relevant field; advanced degree preferred.
Minimum 8 years of experience in regulatory affairs within the medical device industry.
In-depth knowledge of FDA regulations, ISO standards, and global regulatory requirements.
Proven experience in preparing and managing regulatory submissions.
Strong leadership and communication skills, with the ability to collaborate effectively across teams.
Regulatory Affairs Certification (RAC) is a plus.
How to Apply:
Interested candidates should submit their resume and cover letter to ebun@meliolifescience with the subject line "Senior Manager of Regulatory Affairs" by Monday, 4th December 2023. 📧📅
Melio is an equal opportunity employer. 🌐🤝