Regulatory Affairs Specialist

Responsibilities

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

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

Preferred

Bachelors degree in a relevant field preferred

Benefits

401K

Health Benefits: Medical, Dental, Vision

Wellness Program

Life Insurance

Corporate Sponsored Events

Skill growth opportunities

Short Term Disability

Ability to Advance

Working with energetic & creative problem solvers

A mission worthy of your energy and expertise

Instant Systems produces single use supplies, packaging and specialized kits for the rapidly advancing biotechnology sector; specifically in the areas of cell-based assay/culturing, tissue engineering/regeneration, biopharmaceuticals and fermentation.

Norfolk, Virginia, USA

https://instantsystems.com/

Growth Stage

Leadership Team

Tara Ramsey

President & CEO

Uzair R.

Chief Operating Officer

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Qualifications

A minimum of 3-5 years of relevant work experience in regulatory affairs, specifically working to compile and submit 510k applications

Strong knowledge of medical device regulations and standards

Experience with regulatory submissions and interactions with regulatory authorities

Creative problem-solving skills

The ability to balance multiple priorities

Bachelors degree in a relevant field preferred

Required skills

Represents the skills you have, click on the tags, 510(k) Applications, Medical Device Regulations and Standards, Lean Methodology

Preferred skills

Bachelors degree in a relevant field preferred

Experience

3-5 years