Job description

About the Role

This position involves supporting the regulatory success of innovative medical device technologies aimed at improving patient outcomes. The role is based in the United States and involves contributing to global regulatory strategies and guiding products through complex approval and compliance pathways. You will collaborate closely with cross-functional teams, providing regulatory expertise throughout the entire product lifecycle, from initial development to commercialization, combining technical insight, strategic planning, and careful attention to changing regulatory standards.

Key Responsibilities

Prepare and manage regulatory submissions for various authorities, ensuring they are accurate, complete, and meet all regulatory requirements.
Coordinate and maintain communication with regulatory agencies during application reviews and assist in providing timely responses to queries.
Oversee maintenance of product registrations, licenses, certifications, listings, and other regulatory documentation.
Offer regulatory guidance and strategic advice to Product Development teams throughout the design and development stages.
Evaluate changes in product design, quality, and manufacturing to assess regulatory impact and submission obligations.
Review technical documentation for compliance and readiness before submissions.
Stay updated on regulatory changes, standards, and industry guidelines to ensure ongoing compliance.
Help develop and review product labeling, promotional materials, and customer-facing content to ensure regulatory compliance.
Work collaboratively with engineering, quality, clinical, and commercial stakeholders to meet regulatory goals.
Mentor junior regulatory affairs personnel and interns, sharing knowledge and best practices.

Candidate Requirements

A Bachelor's degree or equivalent in science, engineering, biomedical, software, mechanical, or a related technical field.
Experience in regulatory affairs within the medical device or therapeutic goods sectors.
Strong knowledge of medical device regulations, quality systems, and ISO standards related to product development and approval processes.
Proven experience managing, compiling, submitting, and maintaining regulatory filings.
Experience supporting cross-functional teams in a commercial product environment.
Excellent verbal and written communication skills to convey technical information effectively.
Strong organizational skills with ability to handle multiple priorities independently.
Analytical mindset with problem-solving acuity and strong attention to detail.
Self-driven, collaborative, and committed to integrity and high-quality standards.
Passion for driving the success of innovative healthcare technologies.
Preferred experience with U.S., European, and/or Australian medical device regulatory frameworks.
Preferred experience with active implantable medical devices, Class III devices, or knowledge of reimbursement requirements.

Benefits and Work Environment

Participate in advancing cutting-edge medical technology that enhances patient care.
Engage in a collaborative culture focused on innovation and impactful outcomes.
Receive a competitive salary package commensurate with your experience and qualifications.
Collaborate with multidisciplinary teams spanning product development and commercialization.
Gain opportunities for professional growth through mentorship and exposure to global regulatory processes.
Work within an inclusive organization that embraces diverse perspectives and contributions.

Additional Information

This recruitment is managed by the hiring company directly. Applications are reviewed using AI-assisted processes to ensure objective and efficient candidate screening. Final employment decisions are made by the company. Your personal data will be processed in accordance with applicable data protection laws including GDPR, with transparency about how AI tools may assist in assessing applications. For inquiries about data processing, contact the company directly.

Senior Regulatory Affairs Specialist