Director, Regulatory Affairs

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%).