Director of Regulatory Affairs
This role will serve as the FDA regulatory subject matter expert for our medical device business by taking a hands-on role in defining, deploying, and leading regulatory and compliance strategies.
Craft, implement and maintain a Company-wide medical device regulatory affairs system aligned with FDA requirements.
Provide expertise and guidance in interpreting FDA regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.
Develop regulatory strategies for operational improvements and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory agencies.
Oversee the development and implementation of company and departmental SOP’s.
Ensure compliance with applicable FDA, GMP, ISO, protocols and regulations.
Evaluates manufacturing changes for regulatory impact and to ensure compliance.
Define ownership, roles, and responsibilities for specific individuals and teams.
Prioritize resources for initiatives as directed by regulatory affairs with appropriate management of compliance needs, timing and budget.
Develop and maintain compliance training programs.
Establish metrics for evaluating the quality and timelines of submissions.
Ensure department compliance with company policies and procedures.
Manage the preparation of registration packages.
Manage submission data requirements and deliverable dates with regulatory bodies.
Partner with Quality as key contacts for regulatory body interactions including preparation of submissions and strategy for meetings, inspections, and agency responses.
Maintain awareness of regulatory legislation and assess its business impact.
Oversee review and revision of Regulatory Affairs documents.
Provide direction and successful attainment of CE Mark.
A minimum of 8 years regulatory affairs experience interfacing with the FDA in the medical device or medical diagnostics industry. OTHERS NEED NOT APPLY.
Be a results-oriented leader with excellent collaboration and project management skills.
Possess solid decision-making capabilities with strong expertise of regulatory compliance requirements.
CE Mark experience is highly desirable.