Regulatory Affairs Manager- Germany, UK, France, Italy or Spain
Region: Europe, Middle East and Africa
Location: Bonn Germany
Advertising Date: Thu 30 September 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 Manager will play a role in creating a regulatory strategy across programs in the EMEA region. Current regulatory documentation to support the product along with Quality Systems documentation is required. Working closely cross functionally, the Regulatory Affairs Manager ensures that the regulatory documentation is developed, maintained and applied in a practical, coordinated and effective manner and in alignment with company requirements and objectives, and ensures that regulations are complied with globally.
Individual can be located in Germany, UK, France, Italy or Spain
- Develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to market.
- Establish and maintain documentation for CE-marking according to MDR.
- Support post marketing regulatory compliance activities in the EU and abroad as applicable.
- On occasion complete submissions for countries that have complex requirements such as US FDA (PMAs), Australia, Canada and other international markets with minimal supervision.
- Provide regulatory guidance to product development teams to insure the documents the team develops will meet the needs of the regulatory submissions.
- Approve advertising and promotional material and provide guidance and education to cross functional teams regarding promotional and advertising regulatory updates.
- Review events to determine complaint and reportability status. Complete applicable regulatory reporting as requred by Regulatory agencies.
- 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 or higher in science, engineering or related field.
- 6 to 8 years of medical device experience, with work experience in regulatory affairs
- Demonstrated experience in preparing and gaining approval for EU and international based submissions, (GSPRs, Technical Documentation) and lead the company transition from MDD/AIMD to MDR in the EU.
- Lead and negotiated regulatory approval in surrounding EMEA regions.
- Proven track record of increasing responsibilities within regulatory affairs
- Be a self starter and have the ability to work independently to drive projects when needed
- Thorough understanding of global pre & post market regulatory requirements
- Strong organization and time management 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.
How to Apply
To apply, please email your cover letter and resume in English and all relevant certificates in English or German to Gianina Ureta, Human Resources Associate EMEA at firstname.lastname@example.org
Unfortunately, applications send via post cannot be returned.
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets