We are a medical device company that is developing a platform technology to allow for needle-free drug delivery and glucose monitoring.

This person will be responsible for generating and submitting all the regulatory and registration applications necessary to allow the company to market its products domestically and internationally. The Director of RA/CA develops and plans strategies to successfully obtain regulatory approvals/clearances in our target markets. The Director of RA/CA is responsible for overseeing day-to-day Clinical and Regulatory Affairs functions including clinical trial support, compliance, registrations and product submissions.

Major Responsibilities:

Manage the Regulatory Affairs activities for the company. Develop and manage all regulatory submissions, such as: IDE’s, PMA’s, Technical Files, Design Dossiers, CE Mark and Health Canada marketing clearance.

Support all clinical study activity to assure the study designs and study executions are in compliance with applicable regulations.

Interact and negotiate with regulatory agencies worldwide.

Educate and update the leadership team on new and evolving regulatory developments and competitive product approvals.
Review and approve clinical protocols and reports to ensure the clinical study follows the appropriate regulatory strategy for final product approval or marketing claims. Assure collection of appropriate data for regulatory submissions

Ensure that RA/CA policies, procedures, and records are in compliance with applicable regulations and standards.

Perform regulatory reviews of labeling and promotional materials for conformance to regulatory requirements.

Provide training to company personnel on clinical and regulatory issues and developments as appropriate.

Develop and implement departmental policy and procedures.

Identify, develop and motivate the RA internal staff

Identify and manage the appropriate group of Clinical and Regulatory external consultants and advisors

Qualifications:

Bachelor’s degree required, advanced degree preferred

A minimum of 10 years in regulatory/clinical functions of a medical device/diagnostic company.

Participation in at least one successful FDA PMA device submission and Technical Files to Notified Body for CE Mark filing.

A minimum of 3 years of management experience

Comprehensive knowledge of ISO, QSR, CMDR, and MDD requirements

Experience in making presentations to and negotiating with FDA (CDRH) and Notified Body personnel on regulatory submission strategies and product approvals.

Current knowledge of U.S. medical device regulations (FDA QSR) and the Medical Device Directive (MDD/ISO 13485).

Strong written and verbal communication skills

Previous experience with electronic/software driven medical products highly desired

Experience and comfort working in a startup environment that requires the ability to think and plan strategically yet able to function and implement "hands on" with limited administrative support.