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Regulatory Affairs Specialist
Location: Woburn MA
Advertising Date: Thu 30 September 2021
Closing Date: Wed 01 December 2021
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 Specialist 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 click the apply button or 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