11 months ago
Are you wanting to work for a Medical Devices company that is shaking up the way healthcare is provided on a global scale? Tired of working on general maintenance of regulatory files for products that have no way to develop? Looking to work for one of the most talked about start-ups in the medical world right now?
Well then this is the opportunity for you!
What experience you can expect to gain:
- Set up and consult with the senior management on the regulatory systems and strategy for the company’s short and long terms future.
- Support the product development teams in the implementation of regulatory requirements, including preparation and review of design and test documentation.
- Perform regulatory assessment of product changes.
- Coordinate all activities related to domestic and regulatory submission and approval for medical software solutions.
- Prepare, coordinate, and file regulatory submission documents.
- Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
- Prepare, or contribute to the preparation of post-market surveillance plans and evaluate post-market data.
- Drive regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
- Ensure regulatory requirements are met for maintenance of products.
- Stay abreast of current and novel developments in the field.
- As part of a new start-up with a highly collaborative culture, perform other related duties and “pitch in” where needed.
- Support internal and external audits.
- Research and evaluate different risk factors regarding business decisions and operations.
What experience will best serve you:
- Bachelor’s degree or higher.
- 3 to 5 years of proven regulatory experience with class II or III medical devices, and FDA approval for 510k, de Novo for software as a medical device
- Knowledge of the QMS ISO:13485, and MDSAP.
- Experience with new product development standards and documentation for software products.
- Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
- Strong organisational skills; ability to remain organised and productive in fast-paced work environment with competing priorities.
- Work independently, diligently, and efficiently on assigned tasks and projects.
- Collaborate seamlessly with teams.
- Ability to review and provide critical feedback on design documentation.
- Ability to communicate and interact with regulatory agencies and consultants.
- Excellent English written and verbal skills.
- Strong technical presentation skills.