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The Vice President Regulatory Affairs & Quality will be an experienced professional with a track record of success in the medical device industry. The responsibilities of this position are, but are not limited to, the management of regulatory affairs and quality assurance activities for our medical device products in the EU, US and around the world as necessary. This person will also assume the responsibilities of the Person Responsible for Regulatory Compliance (PRRC) per MDR 2017/745.

This person will provide leadership for the regulatory affairs and quality assurance functions. This person will drive the global regulatory affairs strategy, leading the execution of regulatory filings and managing any applicable personnel. The VP of Regulatory Affairs and Quality is able to execute parallel responsibilities with regards to regulatory and quality requirements in all geographies where we intend to conduct business. This position requires developing systems that support the strategic goal to be a leading company in pulmonology, using the candidate’s depth and breadth of experience and knowledge of regulations as well as relationship networks to advance successful medical devices to market. The VP of Regulatory Affairs and Quality will also be tasked with supporting the company as it progresses through its clinical trials, gains regulatory approval, and prepares for commercialization while maintaining compliance.

The VP of Regulatory Affairs and Quality will have excellent presentation skills and be technically competent. He/She will have a desire and capability to grow within an emerging company and within the role. This individual will be able to travel up to 20%.

Essential Roles/Responsibilities:

• Oversee regulatory strategies to ensure earliest possible approvals. Contribute to strategic planning and manage the annual budget to ensure resources are aligned to business priorities.

• Ensure rapid and timely approval on medical devices and continued approved status of medical devices. Ensure the timely and accurate filing of all regulatory documentation, including timely preparation of organized and scientifically valid submissions.

• Oversee device accountability and tracking systems and ensure compliance with labeling regulations and Quality System Regulations. Ensure support on new product development post market surveillance and that regulatory reporting requirements are met. Investigate and make reporting decisions for medical complaints. • Manage relationships, activities, interface and adherence to related guidelines with the FDA and other governmental regulatory agencies, both domestically and abroad.

• Ensure compliance with FDA regulations and interpretations. Manage response to FDA regarding any product information or issues.

• Represent company before global regulatory agencies on major policy matters and decisions regarding products and therapies. Establish and maintain professional and credible relationships with key physicians, consultants, vendors, and co-workers.

• Procure and oversee outside vendors and consultants as required. Maintain superior knowledge of competitive technologies, in addition to medical, technical, and biomedical developments related to peripheral products.

• Establish and maintain a quality system appropriate for the markets we intend to pursue.

Qualifications/Experience:

Minimum Qualifications:

• University degree in a commercial field

• A minimum of 15 years of industry experience and time in a similar role.

• Must have relevant experience developing and executing regulatory strategies for Class III medical devices in the USA and EU, experience in respiratory products a plus

• Highly motivated self-starter, capable of working independently.

• Strong communication, interpersonal, analytical, negotiation and problem-solving skills.

• Ability to interact professionally and effectively with internal and external stakeholders at various levels including members of the Board.

• Proficient in the use of common IT packages, including MS Excel, Word and PowerPoint

Preferred Experience:

• Previous experience in a start-up/re-start/commercial environment