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Sr. Regulatory Affairs Specialist
Location: Northeast US
Posted Date: 06/17/2022
Who We Are
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast growing; dynamic organization and we seek an experience Sr. Regulatory Affairs Specialist to help us with our growth.
**This role is a Hybrid role with mostly remote options available.**
What You’ll Do
This position will report to the Regulatory Affairs Manager who enthusiastically supports professional growth. The Sr. Regulatory Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions to obtain and maintain the necessary regulatory clearances/approvals to allow for commercial supply of Sirtex products. You’ll direct the work of less experienced regulatory staff to extend and develop their skills to ensure the successful registration of Sirtex products and your own professional growth.
In this role, you'll:
- Prepare and submit regulatory submissions, for countries that have complex requirements such as US FDA (PMAs), Australia, Canada, China and other international markets with minimal supervision.
- Prepare product information changes as required by relevant regulatory bodies.
- Lead or compile materials required in license renewals and annual registrations.
- Ensure timely registration of products in compliance with applicable regulations and guidance.
- Review design and product information changes and recommend action.
- Assist with the review of information or publications communicated from the Company to satisfy regulatory and corporate compliance requirements.
- Analyze the scientific content of selected 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.
- Assist with the review of events to determine complaint and reportability status. Assist with completing applicable regulatory reporting as required by those Regulatory agencies.
- Support post market regulatory compliance activities.
- Participate in regulatory inspections and product risk analyses.
- Provide regulatory support to the internal project teams and other departments.
- Undergo formal training events as may be directed from time to time.
- Observe and comply with all Sirtex policies.
- Work within and in assurance to Quality Systems procedures, work instructions and other Quality Systems Requirements.
- Other projects and duties as needed.
Who You’ll Be
Undergraduate college degree is required and within a scientific discipline is preferred but not required. The following skills and traits are needed:
- 5-10 years regulatory affairs experience in the medical device industry.
- Experience in international medical device registrations.
- Knowledge of and experience with global pre- & post market regulatory requirements (such as tracking and interpreting new regulations, registrations/submissions, post-market surveillance, etc.).
- Personable, energetic, responsive, confident and honest. Sense of humor is always welcome.
- Strong organization and time management skills.
- Excellent negotiation skills.
- Self-starter and the ability to work as part of a team.
- Excellent verbal and written communication skills.
- Basic office computer skills (email, word processing, and spreadsheet software).
What to Expect from Us
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:
- Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives.
- A working culture of respect, diversity, and performance to help facilitate an inclusive culture.
- Attractive compensation and benefit packages which are practical, robust, fair, and equitable.
- A place to grow through career development and training opportunities.
- Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world.
Conditions of Employment
- Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
- Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
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.
Be part of an amazing team that is helping to save lives, every day.