Job Description
Job DescriptionDescription:
Join Safeguard Medical – Where Purpose Meets Innovation
At Safeguard Medical, we’re not just shaping the future of emergency medicine—we’re saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts.
Our mission is clear:
To equip and enable responders at every skill level to preserve life in any environment.
Our vision is bold:
To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most.
Our purpose is powerful:
To bring together life-saving products and the knowledge of emergency medical skills that preserve life.
From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we’re building a global movement—one that gives first responders the tools they need to make a difference in the toughest conditions. If you’re driven by impact, inspired by innovation, and ready to grow in a company that’s changing lives—this is your moment.
About the Role
We’re on the lookout for a passionate Regulatory Specialist to join our team onsite full time in Huntersville, NC. This isn’t just a job—it’s a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe.
What You’ll Be Doing in This Role
As a Regulatory Specialist, you’ll be right at the heart of our mission to preserve life. The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities.
This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide.
Your key objectives:
• 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
Requirements:
You won’t just be filling a role—you’ll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most.
Is This You?
We’re looking for someone who’s ready to jump in and make a difference. Could that be you?
- You thrive in a team and bring a positive, can-do attitude to everything you do
- You’re passionate about helping others and want to be part of something that truly matters in emergency medicine
- 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%
You possess the following:
· 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
If you’re nodding along, we’d love to hear from you.
Why Safeguard Medical?
This is more than a career move—it’s a chance to join a fast-paced, purpose-led company where your work truly matters. You’ll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow.
- Be part of a mission-driven organization with global impact
- Work with life-saving technologies and innovative solutions
- Join a collaborative, supportive, and inclusive team
- Build your career in a company that invests in people and progress
Our Culture: Powered by Our DNA
At Safeguard Medical, our culture is built on values that drive us every day:
- Ownership – We take charge, own our impact, and push for success.
- Initiative – We act boldly and do what’s right, fast.
- Curiosity – We ask “why?”, explore better ways, and embrace diverse views.
- Candor – We speak openly and respectfully to align and move forward.
- Humility – We lead selflessly, knowing success is shared.
We believe in learning from each other, valuing every voice, and creating a space where everyone belongs—regardless of background, identity, or ability.
What You’ll Get in Return
We believe great people deserve great rewards. Here’s what we offer to support your wellbeing, growth, and success
- Comprehensive insurance packages – peace of mind for you and your loved ones with medical, dental, vision and life insurance
- Competitive pay & performance bonus – because your impact deserves recognition
- Retirement support – employer contribution to help secure your future
- Generous time off allowance – time to recharge and enjoy life outside of work
- Employee Assistance Program (EAP) – confidential support when you need it most
- Tuition reimbursement &referral programs – invest in your growth and help us grow too
Ready to Make a Difference?
Ready to join our team? We’d love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities.
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 in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.
The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.