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, short term projects and technology or business acquisitions.
- Maintain knowledge of current regulatory requirements, proactively advise the EMC of changes and assure communication throughout the organization.
- Carry out all duties and responsibilities as assigned by the Company in accordance with Company policies, procedures, and applicable laws and regulations governing our business practices.
QUALIFICATIONS
EDUCATION REQUIREMENTS
- Bachelor’s Degree in business or life sciences or equivalent experience required. Master’s Degree is preferred.
EXPERIENCE REQUIREMENTS
- A minimum of 15 years of experience in regulatory affairs.
- A background in ophthalmology is preferred and small company, “hands-on” experience is a plus.
- Must be able to demonstrate the ability to function both strategically and ‘hands on’ in an individual contributor capacity as well as think laterally to ensure the effective management of internal and external resources.
- Proven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting.
- Leadership and management style characterized by vision and teamwork, preparation, communication and negotiation. Successful management of relationships at all levels of the organization.
- High energy and results-oriented individual who is mature and successful in a business environment and is skilled at motivating and inspiring people.
- Well-developed presentation, communication and interpersonal skills, in particular strong oral and written communication skills with regulatory agencies, investors, and key opinion leaders.
- Ability to work self-directed in a fast-paced environment and deal effectively with change.
- Provide the necessary reporting materials and communicate effectively with senior management and the Board of Directors.
OTHER QUALIFICATIONS
- Thorough working knowledge of the medical device industry is required and combination device with pharma experience preferred.
- Ability to exercise sound decision-making and good judgment consistent with a senior level position.
TRAVEL REQUIREMENTS
Periodic travel to leadership meetings and industry conferences may be required
