Regulatory Affairs Specialist
Location: Woburn MA
Advertising Date: Wed 05 January 2022
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. This is an on-site position based in the Woburn MA office and the employee will be required to work in the office on a regular basis.
- 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.
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.
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