Clear Dynamic is revloutioninzing pain management through glass microsphere technology. Our proprietary, water-soluble embolic particles provide targeted treatments for paitents. Developed using advanced materials engineering, our microspheres are designed to safely dissolve in the body, providing a precise and innovative approach to pain intervention. We are a passionate team, dedicated to improving patient outcomes through groundbreaking materials science. Join us as we shape the future of interventional medicine.

About the Opportunity

As Regulatory Affairs Lead you will be responsible for developing and leading the execution of global regulatory strategies and plans to support business objectives and ensure timely market access for the company's novel embolization device and future medical technologies. This is a hands-on role involving direct authorship and ownership of regulatory submissions, review of design documentation and labeling, and coordination with global regulatory bodies. The lead will also serve as the process owner for regulatory activities, responsible for developing, maintaining, and training on regulatory SOPs and procedures. The role requires proactive monitoring of the regulatory landscape and engagement with cross-functional teams to ensure compliance throughout the product lifecycle.

Key Responsibilities

• Develop and lead the execution of regulatory strategies and plans for global markets to support product development, commercialization, and lifecycle management.
• Assess regulatory pathways and identify risks and opportunities to support business planning and product claims.
• Forecast regulatory resource needs based on product development pipelines and anticipated submissions.
• Evaluate regulatory intelligence and monitor global regulatory trends to advise on emerging issues, classification, jurisdiction, and submission requirements.
• Prepare and deliver regulatory updates, presentations, and reports to inform business planning and decision-making.
• Drive alignment between regulatory objectives and broader business goals through proactive stakeholder engagement, including executive management, finance, product development and quality.
• Serve as the regulatory affairs contact for internal and external stakeholders, including partners and suppliers.
• Provide regulatory input into design and risk management activities, including conducting post-market surveillance on competitor products to identify serious adverse events and other emerging safety signals.
• Review and approve product design and risk documentation, clinical/performance data, and product labeling, for regulatory compliance.
• Support the development and review of promotional materials and product claims for compliance.
• Prepare, submit, and manage global regulatory submissions, including technical files, 510(k)s, EU MDR documentation, and other national applications (as applicable).
• Interface with regulatory authorities and notified bodies on behalf of the company throughout the submission and review process.
• Ensure accuracy, completeness, and transparency in the preparation of regulatory documentation and data.
• Participate in audits and inspections and lead preparation of related documentation.
• Serve as process owner for regulatory affairs processes, including creation, maintenance, and continuous improvement of SOPs and associated training.
• Collect data and report on the performance and effectiveness of regulatory affairs processes, including key metrics and trends, to support management review and continuous improvement.
• Maintain regulatory documentation, databases, and archives in a structured and audit-ready format.
• Lead onboarding and continuous education initiatives related to regulatory affairs for new hires and cross-functional team members.
• Provide regulatory input and support to cross-functional teams throughout the product lifecycle, including R&D, Quality, Clinical, and Commercial.
• Support review and development of internal change control procedures and assess the regulatory impact of changes.
• Participate in the investigation, documentation, and resolution of NC/CAPAs from a regulatory affairs perspective, as required.
• Support post-market surveillance activities by monitoring product performance, reviewing complaint data, analyzing safety signals, and contributing to ongoing benefit-risk assessments, as applicable.
• Support vigilance and reporting activities under applicable regulations, including preparation and submission of adverse event reports and periodic safety updates, as required.
• Monitor and interpret changes in global regulatory requirements, standards, and guidance documents to ensure continued compliance and to inform regulatory strategy and submissions.
• Provide input into business development activities, including due diligence for partnerships or acquisitions.
• Represent the company at industry forums, regulatory meetings, or professional associations, as appropriate.
• May mentor and train junior regulatory staff, fostering professional growth and technical expertise within the team.
• Promote a collaborative and inclusive team culture that encourages knowledge sharing and innovation.
• Maintain confidentiality of sensitive company and product information.
• Perform other related duties as assigned to ensure regulatory readiness and product compliance.

About You

• Bachelor's degree in life sciences, engineering, or a related field; Regulatory Affairs Certification (RAC) preferred.
• 5+ years of experience in regulatory affairs within the medical device industry.
• Solid understanding of global regulatory frameworks including FDA, EU MDR, Health Canada, and other international authorities.
• Demonstrated experience preparing and managing regulatory submissions for Class II/III medical devices.
• Knowledge of regulatory requirements across the product lifecycle, including clinical, labeling, and post-market obligations.
• Experience developing, implementing, and maintaining regulatory affairs processes and creating associated standard operating procedures (SOPs) and documentation.
• Strong written and verbal communication skills, with the ability to interact effectively with regulatory bodies, internal teams, and external stakeholders.
• Detail-oriented, self-motivated, and capable of managing multiple projects in a dynamic environment.

Work With Us!

At Clear Dynamic, you'll be part of a team that's transforming lives through innovation.

Here's what you can expect when you join us:

Co-paid Health, Dental, and Vision Insurance
We offer comprehensive coverage to support your health and well-being.

Generous Paid Time Off & Holidays
We value work-life balance and encourage time to recharge.

Professional Development Support
Whether it's a course, certification, or conference, we offer reimbursement for training and growth opportunities.

Once You've Applied

Thank you for your interest in this position. Only those applicants selected for an interview will be contacted.