Job Description

Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launching smart/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that houses real-time Physical Intelligence medical data.

Reports to CEO

Location: Salt Lake City, UT

Overview:

 The Vice President of Regulatory Affairs will be responsible for developing and implementing regulatory strategies to ensure that Xenter’s medical devices meet all regulatory requirements in global markets. This executive will lead the Regulatory Affairs team, collaborate with cross-functional departments, and interact with regulatory agencies to ensure timely and successful product approvals. 

Responsibilities 

Regulatory Strategy and Leadership

• Develop and execute regulatory strategies that align with the company’s business objectives and product development plans.
• Lead the Regulatory Affairs team, providing direction, mentorship, and professional development opportunities.
• Serve as a member of the executive leadership team, contributing to overall company strategy and decision-making.

Regulatory Submissions and Approvals

• Oversee the preparation and submission of regulatory documents, including premarket notifications (510(k)), premarket approval (PMA) applications, and international submissions.
• Ensure timely and successful approval of medical devices by regulatory authorities such as the FDA, EMA, and other global regulatory bodies.
• Maintain up-to-date knowledge of regulatory requirements and changes, ensuring compliance with all relevant regulation

Compliance and Risk Management

• Develop and maintain regulatory policies and procedures to ensure ongoing compliance with regulatory requirements.
• Identify and mitigate regulatory risks throughout the product lifecycle.
• Ensure effective communication of regulatory requirements and expectations to internal stakeholders.

Regulatory Agency Interaction

• Establish and maintain positive relationships with regulatory agencies and notified bodies.
• Act as the primary contact for regulatory agencies, managing communications and negotiations to facilitate product approvals.
• Represent the company in regulatory meetings, audits, and inspections

Cross-Functional Collaboration

• Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to ensure regulatory requirements are integrated into product development and commercialization processes.
• Provide regulatory guidance to cross-functional teams throughout the product development lifecycle.

Minimum Experience

• Minimum of 10 years of experience in regulatory affairs within the medical device industry, with at least 5 years in a senior leadership role.
• Proven track record of successful regulatory submissions and approvals in the US and international markets.
• In-depth knowledge of FDA regulations, ISO standards, and global regulatory requirements for medical devices.
• Strong leadership and team management skills, with the ability to mentor and develop a high-performing regulatory team.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to manage multiple projects and priorities in a fast-paced environment

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