Regulatory Affairs Associate
Regulatory Affairs Associate
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 are a fast growing, dynamic organization.
The Regulatory Affairs Associate is responsible for assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals to allow for commercial supply of Sirtex products. The specialist will collaborate cross-functionally on product development and critical initiatives to own the regulatory activities for global commercialization.
- Leads or compiles all materials required in license renewals and annual registrations.
- Assist with the review of advertising information or publications communicated from the company to satisfy regulatory and corporate compliance requirements in all regions.
- Prepare and submit global registrations and submissions for various geographies with minimal supervision.
- Support post market regulatory compliance activities. (Annual reports, Post Market Activities, Compliance Handling, License Renewals for example)
- Assist with the review of events to determine complaint and reportability status.
- Participate in product risk analysis as required.
- Participate in regulatory inspections as needed
- Undergo all formal Training Events as may be directed from time to time.
- Observe & Comply with all Sirtex Corporate Policies
- Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.
Educational Prerequisites and Skill Requirements
- Bachelor's Degree in Science, engineering or similar
- 2+ years regulatory experience in the medical device industry
- 1+ years of experience in U.S. submissions such as 510K, , IDE's etc
- Knowledge of global pre and post market regulatory requirements
- Be a self starter and have the ability to work as part of a team
- Thorough understanding of global pre & post market regulatory requirements
- Strong organization and time management skills.
- Excellent communication and presentation skills.
What you can expect from Sirtex
- 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
- Physical requirements include: sitting, walking, standing for prolonged amount of time, possible exposure to radiation.
HOW TO APPLY:
To apply, please email your cover letter and resume to Human Resources at firstname.lastname@example.org
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets