Regulatory Affairs Specialist: 510(k)/NDA for Med Devices

Instant Systems Inc; Norfolk (VA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401K

Health benefits

Wellness program

Life insurance

Corporate events

Skill growth

Short-term disability

Career advancement

Energetic team

Mission-driven work

Job summary

Instant Systems Inc is seeking a Regulatory Affairs Specialist to drive successful 510k and NDA approvals in the US, focusing on compliance throughout the product lifecycle. You will collaborate with cross-functional teams and regulatory bodies to streamline submissions.

Ideal candidates have 3–5 years in regulatory affairs, strong knowledge of medical device regulations, and a LEAN mindset. Norfolk-based, full-time role offering growth opportunities and a mission‑driven environment.

Qualifications

• 3–5 years of regulatory affairs experience with 510k submissions.
• Bachelor's degree in a relevant field preferred.
• Strong knowledge of medical device regulations and standards.
• Experience with regulatory submissions and interactions with authorities.
• Solid company-centric ideology.
• Creative problem-solving skills.
• Ability to balance multiple priorities.
• Core values of honesty and respect.
• Desire to be challenged.

Responsibilities

• Represent regulatory affairs and liaise with regulators and cross-functional teams, providing regulatory feedback and guidance.
• Research, develop and implement regulatory and compliance strategies for medical devices.
• Prepare and submit applications and reports to regulatory agencies.
• Respond to information requests from regulatory bodies in a timely and organized manner.
• Maintain current knowledge of regulations applicable to the company.
• Develop and maintain relationships with device reviewers.
• Develop and maintain SOPs, work instructions, and policies for compliance.
• Communicate regulatory impact assessments and submission status reports.
• Supports various audits.
• As assigned.

Skills

Regulatory affairs

510k submissions

FDA interactions

LEAN mindset

Problem solving

Education

Bachelor's degree

Job description

Instant Systems Inc is seeking a Regulatory Affairs Specialist to drive successful 510k and NDA approvals in the US, focusing on compliance throughout the product lifecycle. You will collaborate with cross-functional teams and regulatory bodies to streamline submissions.

Ideal candidates have 3–5 years in regulatory affairs, strong knowledge of medical device regulations, and a LEAN mindset. Norfolk-based, full-time role offering growth opportunities and a mission‑driven environment.