City of Edinburgh
6 months ago
Interested in being a senior member of the regulatory function at a global leader in the field of medicla devices? In bringing new and groundbreaking products, while collaborating with some of the world's largest corporations medical functions?
Well a leading medical device company engaged in the design, development, manufacturing and marketing of ultra-widefield retinal imaging devices are offering exactly that!
You'd get the chance to be:
- Managing and driving regulatory projects, and discussing the strategy with executive management.
- Provide regulatory expertise in the development and registration of the company's new products.
- Responsible for driving 510k, CE and other regulatory documentation and submissions.
- Preparation and Participation in meetings with relevant Competent Authorities.
- Working with CROs on paths to market for new technologies through extensive research.
- Communicate effectively with external and internal parties, building strong relationships.
- Keeping the business up to date with the latest developments in global regulations.
- Provide regulatory guidance in the development and validation of new and existing products.
- Advise clients on regulatory strategy plans for assigned projects.
What experience will serve you best in your application:
- At least 5 years' experience within the Medical Devices industry in a technical or regulatory position.
- Previous exposure to the US regulations, previously submitting 510(k)s, PMAs (Desirable), and attending FDA meetings.
- Degree (or equivalent) in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
- Knowledge of cGMP / Quality System Regulations is essential.
- Fluent English both written and oral is essential.
- Excellent practical experience of regulatory submissions and requirements.
- Widespread experience in the highly regulated medical device market.
- Good awareness of FDA & MHRA systems and procedures.
- Direct experience with Medical Device approvals, specifically with clinical trial requirements.
- Excellent presentation skills are required.