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Role Description

The Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support new clinical indications and expand the HistoSonics product portfolio. This role is responsible for driving regulatory pathways that enable market access, ensuring compliance with applicable pre- and post-market requirements, and guiding regulatory strategy across new product development initiatives.

As a key strategic partner to cross-functional teams, the Director helps advance targeted clinical applications and supports successful product launches across multiple anatomical areas, including but not limited to neurological, abdominal, and women’s health indications. This position is currently an individual contributor role with the opportunity to build and lead a regulatory team as the organization grows.

Key Responsibilities

• Working with the VP of Regulatory Affairs, craft regulatory strategies in support of HistoSonics new clinical applications goals.
• Execute regulatory strategy for HistoSonics product portfolio to ensure timely commercialization of new clinical indications for targeted markets.
• Collaborate with Medical and Clinical teams to define clinical data needs at various stages of market access, including feasibility, pivotal and post-market settings.
• Collaborate with development teams to identify and navigate regulatory requirements and provide guidance to ensure rapid, timely clearance of new and modified products.
• Review and approve, where applicable, Design History File documents, Document Change Requests to ensure compliance and identify when design changes require regulatory submissions prior to implementation.
• Participate and provide regulatory guidance and support to cross-functional teams.
• Serve as a Regulatory reviewer and approver of device labeling and promotional materials, including but not limited to user manuals, website, press release, brochures, company sponsored training activities, published literature and speaker presentations to ensure compliance with applicable regulations.
• Manage Regulatory support staff in the completion of their duties.
• Other duties as assigned or necessary to meet department and business objectives.

Qualifications

• Bachelor's degree, preferably in technical discipline. Regulatory Affairs Certification is preferred.
• 10+ years of progressive roles in regulatory affairs in the medical device/healthcare industry. Experience within regulatory agencies may be considered in lieu of industry experience.
• Experience in handling regulatory affairs for complex electro-mechanical medical devices involving software preferred.
• Experience gaining regulatory market access for devices requiring prospective clinical data.
• Experience with medical device regulations in the US & EU.
• Proven regulatory experience with demonstrated leadership and the ability to thrive in a dynamic, evolving environment.
• Strong written and verbal communication skills, with the ability to translate complex technical concepts for diverse audiences and lead high-level discussions.
• Experience assessing clinical data needs and developing or refining clinical narratives for regulatory submissions.
• Demonstrated ability to build collaborative relationships internally and externally and influence cross-functional stakeholders without direct authority.
• Strong organizational skills with the ability to prioritize multiple deadlines, drive initiatives to completion, and translate strategy into clear product, development, or operational objectives.
• Analytical, detail-oriented problem solver aligned with broader organizational goals.
• Willingness to travel up to 20%.

Benefits

• Comprehensive benefits package for full-time employees.
• Health, dental, and vision insurance.
• Life, short-term and long-term disability insurance.
• 401(k).
• Paid time off.
• More benefits.