Manager, Regulatory Compliance

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.

Sirtex requires regulatory compliance to various global markets. The Regulatory Compliance Manager will be responsible for the overall management of global post market compliance. These include but are not limited to post-market surveillance, vigilance activities, adverse event filing, post-market product/process changes. This person is also responsible for regulatory operations and management of global registrations. This position will be hybrid (Woburn location) or remote.

PRIMARY RESPONSIBILITIES:

* Management and execution of post market compliance to various regulations such as EU MDR, Health Canada Medical Device Regulations, relevant US FDA regulations, Australian TGA requirements and other relevant global market regulations.

* Manage and execute review of events to determine complaint and reportability status. Complete applicable regulatory reporting as required by Regulatory agencies.

* Manage and execute vigilance activities.

* Maintain and manage various post market surveillance reports.

* Provide regulatory guidance to cross functional teams to ensure the documents the team develops will meet the needs of the regulatory submissions.

* Maintain and manage global regulatory approvals and licenses by working across the Regulatory department to ensure ownership and accountability of any required submissions (new and renewals).

* Work across the Regulatory Department to establish and maintain regulatory tracker to various regulatory submissions, reporting responsibilities; communicate status to management on a periodic basis.

* Work with management to determine global registration priorities and resources for new product introduction.

* As required, approve advertising and promotional material and provide guidance and education to cross functional teams regarding promotional and advertising regulatory updates and climate.

* Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards.

* Participate in regulatory inspections as required.

* Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:

* Bachelor's degree or higher.

* Minimum 7 years of medical device/pharmaceutical experience, with 2+ years of proven project management experience in regulatory affairs or similar space.

* Knowledge of Quality System requirements and FDA and/or International product approval process.

* Ability to prepare and present technical data to all levels of the organization as well as international regulatory bodies and key opinion leaders.

* Proven effective leadership skills to guide, mentor, and develop team members to meet or exceed project schedules and corporate filing deadlines.

* Proven ability to lead and work effectively in cross-functional teams * Strong organization, project management and time management skills.

The target base salary range for this position will range from $131,000 to $137,000 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 10% for this position)and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

Our EEO statement...

Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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.

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.