Senior Regulatory Affairs Specialist

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.

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.

• 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 addition to the expected base compensation, this role is eligible to participate in Sirtex's incentive programs (target bonus of 5% for this position)and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.