Hiring Regulatory Affairs Manager at Pulmair Medical, Inc.

Regulatory Affairs Manager

Primary Responsibilities

– The Manager of Regulatory Affairs reports to the President/CEO.
– Manages all Regulatory Affairs (RA) strategies, policies, documentation, and contacts.
– Assures appropriate registration interactions occur with regulatory agencies to expedite regulatory approvals.
– Ensures commitments related to regulatory issues are met.
– Accountable for RA submissions, determining the regulatory site standards, and approving associated technical documents and operating procedures.
– Responsible for determining vigilance reporting requirements to various NB/CA and for communicating changes with notified bodies.

This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.

Scope of Work/ Skill Level:

– Acts as liaison with FDA and international regulatory authorities to ensure that regulations are communicated through company policies and procedures,

– Develops regulatory plans and strategies for Pulmair devices.

– Organizes, prepares, and reviews FDA applications and other regulatory documents, including 510(k)’s, Pre-market Approval Applications, Investigational Device Exemptions, and Medical Device Reports as needed.

– Organizes, prepares, and reviews applicable OUS applications and other regulatory documents, including the design dossier.

– Reviews product labeling, marketing materials, and changes to manufacturing processes to ensure compliance with regulatory requirements.

– Reviews regulations, guidances, external standards and communicates regulatory requirements to the appropriate individuals in the organization.

 Preferred Qualifications:

– Bachelor’s Degree in a scientific field with a minimum of 5 year’s experience working in the medical device or similarly regulated industry,

– Comprehensive knowledge of regulatory procedures and practices (e. g. FDA, MDR, etc.)

– Prior expertise interacting with professional staff to achieve goals and operational results,

– Expertise in regulatory strategy, documentation, and negotiation,

– Working knowledge of statistical methodologies.

– Excellent, proven, writing skills.