Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location:

Huntersville, NC

Company:
Safeguard Medical

Full‑time, onsite position.

Join our team as a Regulatory Affairs Specialist to support the execution of regulatory strategy, registrations, and life‑cycle management of life‑saving medical devices.

• Review labeling, training, and promotional materials
• Support product and shipping release
• Maintain FDA’s GUDID database
• Update and review technical file updates
• Review external standards
• Provide support for government queries and registration documentation requirements
• Review change orders and assess regulatory impact of product changes on U.S. and international strategy and submissions
• Support post‑market regulatory compliance activities for U.S./International approvals
• Assist with development and maintenance of regulatory affairs department procedures
• Comply with applicable FDA and international regulatory laws/standards
• Ensure ISO and FDA export requirements are met, as required
• Coordinate and prepare document packages for regulatory submissions, internal audits and inspections
• Ensure all materials support submissions, license renewals and annual registrations
• Keep abreast of regulatory procedures and changes
• Provide support to Customer Service

• Bachelor’s degree (or equivalent experience)
• At least 2 years of regulatory affairs experience in medical devices
• Working knowledge of domestic and global regulations and guidance (FDA, MDD, EU MDR, ISO 10993, etc.)
• History of successful interactions with global regulatory authorities
• Computer proficiency (MS Office, Outlook, internet research)
• Ability to travel up to 15 %
• Strong verbal and written communication skills
• Team‑working, organizational, and problem‑solving skills
• Ability to focus on milestones and manage obstacles under time constraints
• Excellent judgment in all areas of responsibility

• Thrives in a team and brings a positive, can‑do attitude
• Passionate about helping others in emergency medicine
• Can focus and achieve scheduled milestones with contingency planning
• Strong communication and collaboration at all organizational levels
• Willing to travel and adapt to evolving project needs

• Comprehensive insurance (medical, dental, vision, life)
• Competitive base pay with performance bonus
• Retirement support with employer contributions
• Generous time‑off allowance
• Employee Assistance Program (EAP)
• Tuition reimbursement and referral programs

• Ownership – take charge, own impact, push for success
• Initiative – act boldly, do what’s right fast
• Curiosity – ask “why?”, explore better ways, embrace diverse views
• Candor – speak openly and respectfully to move forward
• Humility – lead selflessly, share success

Safeguard Medical is proud to be an equal‑employment‑opportunity and affirmative action employer. We are committed to a work environment that supports, inspires, and respects all individuals and applies merit‑based personnel processes without discrimination based upon race, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic.

We seek to recruit, develop, and retain a diverse talent pool.