Regulatory Affairs Specialist - Medical Devices
Posted on Sep 12, 2019 by Job Juncture
Highly respected, global medical devices company seeks a Regulatory Affairs Specialist to work on domestic and global medical device submissions, compiling regulatory documentation world-wide.
The Regulatory Affairs Specialist will:
- Prepare domestic and international submissions (including CE-mark dossiers). This will include new products and product changes.
- Write submission content for new device registrations and variations
- Act as the regulatory affairs subject matter expert on product development teams, developing and executing regulatory plans and providing regulatory impact information for project options.
- Support new and currently marketed products providing labeling advice and post market follow up activity requirements. Update technical files and design dossiers as required along with developing strategy and the creation of change notifications to regulatory agencies.
- Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals.
- Bachelor's degree in a scientific or technical field, eg. engineering, biological science, materials science
- 2+ years experience in medical device regulatory affairs, preferably with successful FDA and EU notified bodies submission experiences.
- Experience with medical device product registration and licensing is required.
- Working understanding of US, EU, Canada regulations on medical devices
- Excellent analytical and statistical skills
- Working knowledge of Microsoft Office Suite
- Strong communications skills, oral, written and electronic
- The ability to manage multiple competing priorities under tight timelines, and work independently with international oversight
- Exceptional attention to detail.