Regulatory Affairs Manager
Location: Woburn Ma
Advertising Date: Mon 17 June 2019
Sirtex requires various regulatory approvals to manufacture and supply its products in order to operate commercially. Current regulatory documentation to support the product along with Quality Systems documentation is required. Working closely with the Quality Assurance personnel, 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.
- Develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market
- Be familiar and keep up to date with FDA medical device regulations, European Medical Device Directive/Medical Device Regulation, and/or other global regulations where Sirtex products are supplied
- Completes submissions for countries that have complex requirements such as US FDA (PMAs), Australia, Canada, China 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.
- Monitor progress of applications through regulatory system
- Maintain regulatory approvals and licences
- Approve advertising and promotional material and provide guidance and education to cross functional teams regarding promotional and advertising regulatory updates and climate
- Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Support post market regulatory compliance activities
- Participate in regulatory inspections as required
- Observe and comply with all Sirtex Corporate Policies
- Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements
- Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements
Education and Skills Requirements
- Bachelor's degree.
- 7 to 10 years of medical device experience, with work experience in regulatory affairs.
- Experience in the preparation of 510(k) or PMA submissions for FDA and Design Dossier Files for EU.
- Knowledge of Quality System requirements and FDA and/or International product approval process
- Ability to prepare and present technical data to all levels of the organisation as well as international regulatory bodies and key opinion leaders.
- Proven effective leadership skills to guide, mentor, and develop staff members to meet or exceed project schedules and corporate filing deadlines
- Proven ability to lead and work effectively in cross-functional teams
- Basic office computer skills (email, word processing, and spreadsheet software
- Excellent written and verbal communications 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 click the apply button or email your cover letter and resume to Human Resources at firstname.lastname@example.org