Vice President, Regulatory Affairs

PURPOSE OF JOB

As Vice President of Regulatory Affairs, you will oversee all facets of the company’s Regulatory Affairs, providing oversight for all U.S.

and international regulatory matters, including filings and interactions with regulatory authorities.

The VP should be able to think strategically about the development pipeline for the company and assess which products are most likely to move through the regulatory process efficiently.

The Vice President should be able to develop a tight timeline and coordinate the activities of all departments towards achieving a high-quality (defined as first time acceptance) and on-time submission.

He or she should know regulatory road maps for medical devices and preferably combination drug-device products, which will speed up the clinical trial cycle, the regulatory process and garner more government resources.

MAJOR DUTIES AND RESPONSIBILITIES



* Identify, plan, prepare, review and direct regulatory submission in support of timely launch for new and evolving products.


* Acts as the PRRC to manage the regulatory strategy globally and be the key point person with FDA regarding US approvals and notified bodies regarding OUS approvals.


* Own the Regulatory Affairs function to support submission information and other items to the FDA and notified bodies as required.


* Establish and maintain strong professional relationships with regulatory agencies.

Serve as a primary liaison and maintain effective working relationships with regulatory agencies on all matters.


* Interact on a regular basis with the CEO, CTO, and the Executive Team to ensure that business objectives are aligned and that the Company is performing to agreed-upon goals.


* Review and provide input to labeling and marketing programs in reference to regulatory requirements, including responsibility for ensuring that advertising and promotional materials are compliant with regulatory requirements and guidance.


* Interface with regulatory agencies, external experts, and representatives as needed to accomplish assigned task.


* Ensure compliance with established regulations and maintain the highest standard of business and personal ethics.


* Support company goals and objectives, policies and procedures that comply with FDA Quality Management System Regulations (QMSR), ISO 13485, EU MDR, and UKCA/UKMDR, and any other applicable domestic or international requirements.


* Maintain a professional and credible image with key physicians, distributors, consultants, vendors, and co-workers.


* Actively work to promote team building and morale within the department.


* Manage consultants supporting him/her in the position.


* Recruit, hire, train, manage and develop Regulatory Affairs staff members.


* Develop and implement the annual operating and capital budgets to meet long term company and department objectives.


* Participate in the planning of long-term development programs, sh...