Agilik’s Strydr is a non-invasive, pediatric gait rehabilitation device designed for children with crouch gait and knee-extension disorders often found in patients with Spinal Bifida and Cerebral Palsy. Instead of helping patients walk, our goal is to enable them to Stand Taller, Walk Stronger.™
Strydr is considered a Class 2 Medical Device by the FDA and a Class 1 Medical Device by Health Canada and undergoing clinical trials at the NIH Clinical Center in Bethesda, Maryland.
Reporting to the CEO, the impact of this position is significant. The Manager of Quality Assurance and Regulatory Affairs is the point of contact for all regulatory communications inclusive of FDA and Health Canada.
In addition to creating and maintaining the Quality Management System (QMS) you will manage all QA and RA mandates inclusive of budgeting and strategy.
You get to
- Manage the interface with the FDA & Health Canada for new product submissions, compliance, and registration
- Prepare and manage the product approval processes for multi-agency acceptance in North America and Europe
- Knowledge of MDSAP and ISO 13485 audits
- Success in developing submissions for product registrations and approvals
- Developed solutions for Quality Management ‘preferably’ in a powered medical device domain
- Experience navigating the complex bureaucracy of the Medical Device approval process
As the interface between senior management, engineers, and regulatory agencies, you will manage the quality and regulatory efforts to bring Agilik’s Strydr to market. Besides a friendly, easygoing environment, a very competitive remuneration inclusive of a quality benefits plan.
Please send your resume in absolute confidence to Mark Strong firstname.lastname@example.org and be assured that your resume will be reviewed by an expert.
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