Senior Regulatory Affairs Specialist

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

The Senior Regulatory Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses, providing regulatory support to cross-functional initiatives as required, and directing the work of less experienced regulatory staff to extend and develop their skills for the successful global registration and commercialization of Sirtex products.

PRIMARY RESPONSIBILITIES:

• Prepare and file regulatory submissions with minimal supervision, for countries that have complex requirements such as US FDA (e.g., 510(k), PMA, etc.), Australia, Canada, China and other international markets.
• Prepare product information changes as required by relevant regulatory bodies.
• Lead or compile all materials required in license renewals and annual registrations.
•  Drive timely registration of products in compliance with applicable regulations and guidance.
• Conduct regulatory assessment on design, manufacturing, labeling and other product information changes and recommend action.
• Review procedures for compliance to regulatory requirements as well as support updates to other Quality system procedures as required.
• Assist with the review of advertising information or publications communicated from the company to satisfy regulatory and corporate compliance requirements.
• Analyze the technical content of new registration packages to ensure they comply with country regulations prior to submission.
• Assist with the review of new clinical trial protocols to ensure regulatory requirements and future regulatory needs are met
• Liaise with industry associates and regulatory bodies as required
• Review events to determine complaint and reportability status. Support or lead, as assigned, any regulatory reporting required by Regulatory Agencies.
• Support post-market regulatory compliance activities.
• Participate in regulatory inspections/audits as required.
• Participate in product risk analyses as required.
• Provide regulatory support to internal project teams and other departments as necessary.

Qualifications

• Bachelor’s degree in science or equivalent
• 4+ years regulatory experience in the medical device industry
• Experience in international medical device registrations and U.S. submissions
• Knowledge of global pre- and post-market medical device regulatory requirements
• Strong organization and time management skills
• Self-starter and the ability to work independently with minimal supervision as well as part of a team
• Excellent verbal and written communication skills, and strong negotiation skills
• Basic office computer skills (email, word processing, and spreadsheet software

This role is critical for organizations aiming to stay ahead of evolving security threats and regulatory requirements, and ensures the integrity, confidentiality, and availability of information assets.

The target base salary range for this position will range from $110,000 to $136,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements.  Actual compensation may vary depending on the confirmed job-related skills and experience.

In