Safeguard Medical
Regulatory Affairs Specialist
Safeguard Medical, Huntersville, North Carolina, United States, 28078
Regulatory Affairs Specialist
Location: Huntersville, NC
Company: Safeguard Medical
Full‑time, onsite position.
About the Role 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.
Key Objectives
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
Requirements
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
Ideal Candidate
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
Benefits & Perks
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
Our Culture
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
Legal & Equal Opportunity Statement 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.
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Company: Safeguard Medical
Full‑time, onsite position.
About the Role 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.
Key Objectives
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
Requirements
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
Ideal Candidate
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
Benefits & Perks
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
Our Culture
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
Legal & Equal Opportunity Statement 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.
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