Regulatory Affairs Specialist

Instant Systems Inc.; Norfolk (VA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

401K

Health benefits

Wellness program

Life insurance

Company events

Professional growth

Short-term disability

Career advancement

Job summary

Instant Systems Inc. seeks a Regulatory Affairs Specialist to drive 510k and NDA approvals, coordinating documentation, submissions, and timelines with USFDA.

You will collaborate with cross-functional teams to ensure device compliance, maintain regulatory knowledge, and manage audits; 3–5 years in regulatory affairs and a relevant degree are preferred.

Qualifications

• 3–5 years of regulatory affairs experience focused on 510(k) submissions.
• Bachelor's degree in a relevant field preferred.
• Strong knowledge of medical device regulations and standards.
• Experience with regulatory submissions and interactions with regulatory authorities.
• Creative problem-solving and ability to balance multiple priorities.
• Core values of honesty and respect.

Responsibilities

• Represents regulatory affairs and liaises with regulatory bodies when working with cross-functional teams.
• Researches, develops and implements regulatory strategies for medical devices per applicable regulations.
• Prepares and submits applications and reports to regulatory agencies.
• Responds to information requests from regulatory bodies in a timely manner.
• Maintains current knowledge of regulations applicable to the company.
• Develops relationships with device reviewers through written and oral communications.
• Maintains SOPs, work instructions and policies to ensure compliance.
• Compiles regulatory impact assessments and submission status reports.
• Supports audits.

Skills

Regulatory affairs

Regulatory submissions

Problem solving

Prioritization

Honesty & respect values

Education

Bachelor's degree

Job description

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

To Be Considered You'll Need

• 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.

You Will Thrive If You

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

Company Benefits & Perks

• 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