QUALIFICATIONS / EXPERIENCE

• Intimate understanding of FDA and ISO regulations. Understanding of, and experience with, MDR and MDSAP, also considered beneficial.
• Experience in a Regulatory role within a medical device manufacturing company.
• Knowledge of global regulatory requirements for medical devices. Specific knowledge of single-use sterile medical devices considered highly desirable.
• Experience with incident reporting for adverse events and recalls to regulatory authorities.
• Knowledge of global quality requirements for medical devices.
• A common sense, pragmatic approach to the application of regulations and standards.
• Intermediate to advanced proficiency in MS office applications.
• Internal QMS auditing experience.
• Ability to effectively interact with a broad range of people/ organisations including, regulatory bodies.
• Excellent written and verbal communication skills, proven leadership and problem-solving aptitude.
• Team oriented and respectful.
• Exhibit initiative, take ownership, and possess the ability to influence others.

REMUNERATION WILL BE COMMENSURATE WITH QUALIFICATIONS AND EXPERIENCE.

Job Type: Full-time
Pay: $100,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Application Question(s):

• Do you have an intimate understanding of FDA and ISO regulations?
• Do you experience in a Regulatory role within a medical device manufacturing company?
• Do you have knowledge of global regulatory requirements for medical devices?

Ability to Commute:

• Fremont, CA 94538 (Preferred)

Ability to Relocate:

• Fremont, CA 94538: Relocate before starting work (Required)

Work Location: In perso

ROLE PURPOSE

The Regulatory Affairs FDA Professional is responsible for managing all facets of Nova Eye Medical’s USA regulatory strategy. You will work closely with senior management to develop this strategy and there will be a strong emphasis on engagement with the US Food and Drug Administration (FDA) and the prioritization of 510(k) submissions and IDE’s to support the Company’sambitious product development pipeline. This is expected to entail the preparation and submission of multiple 510(k) applications during the upcoming 24-month period to support existing and new products, and to expand the product labelling of existing cleared products to include additional clinical indications. There may be IDE applications.
The Regulatory Affairs FDA Professional is a hands-on position that will see the incumbent work with a wide number of stakeholders, both internal and external, to manage the Company’s product registration requirements in the USA. We are looking for someone with attention to detail and a proven background in the global regulatory landscape with key expertise in the USA/FDA.
The Regulatory Affairs FDA Professional will be a key member of corporate team providing regulatory strategy, advice and support to the global business.