Regulatory Affairs Specialist

Apreo Health is a clinical-stage medical device company redefining the role of intervention in severe emphysema. Originating at The Foundry, an acclaimed medtech venture incubator, funded by a prestigious syndicate of venture capital investors and led by a team with deep medtech and pulmonary expertise, Apreo is developing the BREATHE Airway Scaffold, a tissue-sparing therapy designed to expand access to meaningful treatment. The company recently closed a sizable round of financing to support the BREATHE-3 IDE pivotal study and early commercialization efforts. Apreo’s therapy is designed to reset the standard of care by demonstrating a durable treatment effect across a broad spectrum of the emphysema patient population.

Apreo is seeking a Regulatory Affairs Specialist to support the strategy and execution of regulatory submissions for medical device products, ensuring compliance with FDA, EU MDR, and international regulations and standards. This includes providing regulatory guidance and deliverables for the full product lifecycle, from early-stage development through clinical studies and post-market changes.

Responsibilities

• Plan, manage and prepare document packages for regulatory submissions, supplements, and reports, both US and international, including but not limited to FDA submissions (IDE and PMA), EU MDR technical documentation, European Breakthrough Device Designation, and product registrations.
• Manage and support regulatory plans and regulatory deliverables for new products or projects.
• Support Q-submissions (e.g., Pre-submission meetings, Sprint meetings) with FDA and meetings with notified bodies, EMA expert panels, or other regulatory agencies.
• Provide input throughout the product development lifecycle to ensure products developed by the Company comply with applicable regulatory and quality system requirements.
• Provide regulatory input and conduct reviews and approvals in quality system-related activities and assessments, engineering change orders, risk management, clinical evaluation, marketing materials, and product development.
• Assist in development/maintenance of regulatory operational procedures and practices.
• Support inspections and audits by FDA (i.e., pre-approval inspections), notified body (initial ISO 13485 and MDR certifications), and other regulatory agencies.
• Represent regulatory processes during internal audits.
• Collaborate with cross-functional teams to support development and production of new product configurations.
• Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control assessment and approvals.
• Support multiple projects, department initiatives, and day-to-day tasks.
• Perform other duties as assigned.
  
  

Qualifications

• Minimum 2 years medical device regulatory affairs experience. FDA Class III device pre-market experience and/or implant experience preferred.
• Previous experience in FDA and/or CE Mark submissions
• Bachelor’s degree in scientific, regulatory or healthcare field, e.g., life sciences, engineering, regulatory affairs, legal, or equivalent required.
• Advanced degree or specialized regulatory coursework preferred
• Demonstrated knowledge and application of quality system requirements (ISO 13485), FDA 21 CFR Part 820, EU Medical Device Regulation other global regulatory requirements and quality standards.
• Excellent attention to detail and the ability to manage multiple tasks concurrently.
• Demonstrated proficiency in writing, verbal communication, active listening, problem-solving, and team-building skills.
• Fast learner, takes ownership of their work with minimal prompting from others
• Collaborates with cross-functional partners to bring together ideas, data and insights to drive continuous improvement.
  
  

This position is for an onsite role at our facility in Menlo Park, California. Occasional remote work may be possible. This position does not offer relocation support. Candidates must reside in or be willing to relocate to the area at their own expense.

Please note that we are currently unable to offer visa sponsorship for this position. Candidates must be authorized to work in the United States without the need for sponsorship now or in the future. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Inquiries and applications (resume cover letter) should be submitted directly to: Sherry Kim, sherry.kim@apreohealth.com.