Senior Regulatory Affairs Specialist

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

📋 Description

• Prepare submissions for regulatory bodies.

• Communicate with regulatory authorities regarding applications under review and coordinate responses to inquiries.

• Manage product and site licenses, registrations, certificates, and listings.

• Collaborate closely with the Product Development team, offering regulatory guidance and input on the design of new products.

• Evaluate proposed design, quality, and production modifications to determine regulatory submission strategies.

• Review technical documentation for accuracy and completeness to support regulatory submissions.

• Monitor and assess updates to regulations, standards, and guidance documents to ensure continued compliance with regulatory requirements.

• Assist in the development of labeling content and review for compliance before release.

• Aid in the evaluation of advertising and promotional materials in accordance with national regulatory standards.

• Provide mentorship to junior RA Specialists and interns.

⛳️ Requirements

• Tertiary qualification in a science or engineering related field (e.g., software, biomedical, mechanical).

• Experience in the medical device or therapeutic goods industry, preferably within regulatory affairs.

• Comprehensive understanding of medical device regulations and relevant ISO standards related to the product development and approval process.

• Proven experience in managing, compiling, submitting, and maintaining regulatory filings.

• Demonstrated capability to work with cross-functional teams in a commercial setting.

• Strong written and verbal communication abilities.

• Effective time management skills and the capacity to work independently.

• Self-motivated team player, exhibiting a high level of personal integrity.

• Strong analytical skills and attention to detail to identify and resolve issues.

• A strong desire to contribute to the growth of the organization.

• Experience with European, US, and/or Australian Medical Device Regulations (desirable).

• Experience with Active Implantable and/or Class III medical devices (desirable).

• Experience with Australian reimbursement requirements (desirable).

🏝️ Benefits

• Saluda Medical values diversity and equal opportunity.

• Committed to forming a team that represents a variety of backgrounds, perspectives, and skills.

• Belief that individuals are the source of inspiration and innovation.