Responsibilities :
The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.
Support Product Development & Registration :
- Provides strategic input and technical guidance on global regulatory requirements to product development and clinical teams.
- Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
- Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
- Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
- Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
- Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
- Provides regulatory guidance on strategy for proposed product claims / labeling.
- Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
- Manages electronic and paper registration development.
- Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
- Prepares cross-functional teams for interactions with regulatory authorities including panel meetings / advisory committees.
Support Post approval / Post market Activities :
- Ensures process is in place for review and approval of advertising and promotion to ensure regulatory compliance.
- Develops, implements, and manages systems to track required reports, supplemental submissions, and other post marketing commitments.
- Reviews and approves required reports, supplemental submissions, and other post marketing commitments to maintain product registrations.
- Reviews and approves change controls to determine the level of change and consequent submission requirements.
- Develops, implements, and manages appropriate SOPs and systems to track, manage, report, and communicate product-associated event complaints, recalls, market withdrawals and vigilance reports.
- Adapts post market strategy based on consideration of factors such as HTA, reimbursement, group purchasing pressures, state / provincial / regional restrictions, and other legislative / regulatory requirements.
Other Responsibilities
- Serves as company's deputy Person Responsible for Regulatory Compliance (PRRC).
- Participates in Corporate initiatives as appropriate.
- Supports Quality Policy and Quality System.
Requirements :
- Bachelor's degree and a minimum of 12 years of experience in Regulatory Affairs in the medical device industry.
- Demonstrated strength in regulatory submissions activities. Class III, PMA experience is strongly desired.
- Commercial and post-market experience is required.
- Knowledge of international regulatory requirements, EU MDR.
- Strong project management skills and experience.
- Proficient in timely review of technical data and clinical data.
- Demonstrated success in fast-paced start-up, entrepreneurial work environments.
- Ability to write clear, concise, and well thought out technical documents.
- Strong leadership, organizational, interpersonal skills.
- Excellent presentation skills.
- Computer skills : MS Word, PowerPoint,Excel
- Hybrid role.
- Minimal travel (less than 10%).
30+ days ago