Principal Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer Regulatory Affairs assistance for product development, sustaining engineering initiatives, and compliance-related activities.

• Formulate regulatory strategies, prepare worldwide regulatory submissions, and collaborate with cross-functional teams.

• Keep track of new and evolving regulations, evaluate their impact on the business, and suggest suitable actions.

• Examine device labeling, advertising, and promotional materials to ensure compliance with approved submissions and relevant global regulations.

• Maintain comprehensive and up-to-date regulatory files, product registrations, and supporting documentation.

• Prepare for and facilitate communications with regulatory agencies and Notified Bodies concerning pre-submission strategies, regulatory pathway development, testing requirements, and follow-up for submissions under review.

• Serve as the company's representative, cultivating and sustaining positive relationships with device reviewers.

• Evaluate and authorize design and manufacturing modifications while ensuring adherence to applicable regulations.

• Support complex product lines, including product integrations, sterilization processes, and other specialized projects or strategic initiatives.

• Actively engage in regulatory collaborations and alignment with other regulatory experts to support product integration efforts.

⛳️ Requirements

• Bachelor's degree in a scientific or technical field.

• At least 7 years of experience in Regulatory Affairs within the medical device sector.

• Proven experience with regulatory obligations for implantable or active implantable medical devices.

• Established experience supporting product development and sustaining activities for implantable or active implantable medical devices.

• Experience in preparing regulatory submissions for medical devices.

• Demonstrated experience working within a product development framework and design controls.

• Strong knowledge of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices.

• Experience leading FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions.

• Exceptional written and verbal communication, along with technical writing and editing skills.

🏝️ Benefits

• Saluda Medical values diversity and promotes equal opportunity.

• Dedicated to building a team that reflects a variety of backgrounds, perspectives, and skills.

• Uphold integrity – Lead with courage, transform lives, and challenge the status quo to achieve excellence together.