Safeguard Medical · 1 month ago
Regulatory Affairs Specialist
Huntersville,NC,US
Full-time
Onsite
Entry, Mid Level
2+ years expSafeguard Medical is dedicated to shaping the future of emergency medicine and saving lives through innovative solutions. The Regulatory Affairs Specialist will play a crucial role in executing regulatory strategies for product registration and lifecycle management, ensuring compliance with FDA and international regulations while supporting cross-functional teams.
Health CareMedicalTraining
Responsibilities
Reviewing labeling, training, and promotional material
Supporting product and shipping release
Maintaining FDA’s GUDID database
Updating and reviewing technical file updates
Reviewing External Standards
Supporting business with government queries and registration documentation requirements
Reviewing Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions
Supporting post market regulatory compliance activities for US/International product approvals
Assisting with the development and maintenance of regulatory affairs department procedures
Complying with applicable FDA and international regulatory laws/standards
Ensuring relevant ISO and FDA Export requirements are met, as required
Performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
Ensuring all materials comply to support submissions, license renewal and annual registrations
Keeping abreast of regulatory procedures and changes
Providing support to Customer Service
Qualification
Required
Bachelor's Degree required
At least 2 years of Regulatory Affairs experience in Medical device
Working knowledge of relevant domestic and global regulations and guidance
History of successful interactions with global regulatory authorities
Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems
A combination of education and experience may be considered
Knowledge of FDA, MDD, EU MDR
Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility)
RAC certification is a plus
Ability to focus and achieve scheduled milestones, including contingency planning
Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization
Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed
Exercise outstanding judgment in all areas of responsibility
Ability to travel up to 15%
Benefits
Comprehensive insurance packages
Competitive pay & performance bonus
Retirement support
Generous time off allowance
Employee Assistance Program (EAP)
Tuition reimbursement & referral programs
Company
Safeguard Medical
Safeguard Medical is a supplier of emergency medical technologies and specialized training tailored for the first responder market.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
A
Adam R. Johnson
Chief Executive Officer
Recent News
Google Patent
2025-05-06
Google Patent
2025-02-16
2025-02-16
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