Regulatory Affairs Specialist

Instant Systems•Norfolk, VA

18h

About The Position

The Regulatory Affairs Specialist (RAS) works to gain successful 510k approval by leveraging their skills and expertise to anticipate regulatory requirements and integrate compliance into project plans. The RAS streamlines preparation and submissions, by ensuring documentation is accurate, complete, organized and accessible. The RAS will work effectively with other departments to compile information and ensure that compliance requirements are met throughout the product lifecycle. Primary function: successfully gain 510k & NDA approval with USFDA Other responsibilities: Represents regulatory affairs and serves as a liaison between regulatory bodies when working with cross-functional teams by providing regulatory feedback and guidance throughout the product development cycle. Research, develop and implement regulatory and compliance strategies for new and modified medical devices in accordance with applicable regulatory bodies. Prepares and submits applications and reports to applicable regulatory agencies of medical devices. Responds to all requests for information from regulatory bodies in a timely and organized manner. Maintains a current and working knowledge of regulations applicable to the company. Develop and maintain positive and professional relationships with device reviewers through oral and written communications. Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Compiles and communicates regulatory impact assessments and submission approval status reports. Supports various audits. Other Responsibilities As assigned

Requirements

A minimum of 3-5 years of relevant work experience in regulatory affairs, specifically working to compile and submit 510k applications
Bachelors degree in a relevant field preferred
Strong knowledge of medical device regulations and standards
Experience with regulatory submissions and interactions with regulatory authorities
Solid company-centric ideology.
Creative problem-solving skills.
The ability to balance multiple priorities.
Core values of honesty and respect.
The desire to be challenged.

Nice To Haves

Enjoy an autonomous work environment.
Have a LEAN mindset.
Are the first person to help.
Seek out opportunities to bring added value.

Responsibilities

Successfully gain 510k & NDA approval with USFDA
Represents regulatory affairs and serves as a liaison between regulatory bodies when working with cross-functional teams by providing regulatory feedback and guidance throughout the product development cycle.
Research, develop and implement regulatory and compliance strategies for new and modified medical devices in accordance with applicable regulatory bodies.
Prepares and submits applications and reports to applicable regulatory agencies of medical devices.
Responds to all requests for information from regulatory bodies in a timely and organized manner.
Maintains a current and working knowledge of regulations applicable to the company.
Develop and maintain positive and professional relationships with device reviewers through oral and written communications.
Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
Compiles and communicates regulatory impact assessments and submission approval status reports.
Supports various audits.
Other Responsibilities As assigned