Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Sirtex Medical is a global healthcare business with offices in the U.S., Australia, 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.
The Senior 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, and directing the work of less experienced regulatory staff to extend and develop their skills to ensure the successful registration of Sirtex products.
- 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
- Leads or compiles all materials required in license renewals and annual registrations
- Ensures 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
- Analyse 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 requlatory needs are met
- Liaise with industry associates and regulatory bodies as required
- Assist with the review of adverse event & customer complaint reports
- Support post market regulatory compliance activities
- Participate in regulatory inspections as required
- Participate in product risk analyses as required
- Provide regulatory support to internal project teams and other departments as required
Education and Skill Requirements
- Bachelors Degree in Science or affiliated program
- 4+ years regulatory experience in the medical device industry
- Experience in international medical device registrations
- Knowledge of global pre- & post market regulatory requirements
- Excellent negotiation skills
- Self-starter and the ability to work as part of a team
- Excellent oral and written communication skills
- Basic office computer skills (email, word processing, and spreadsheet software)
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
HOW TO APPLY:
To apply, 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
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