Regulatory Affairs Specialist

Safeguard Medical; Huntersville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Safeguard Medical is seeking a Regulatory Affairs Specialist based in Huntersville, North Carolina. This role involves managing regulatory submissions and ensuring compliance with FDA standards for unique medical products. The position demands a Bachelor's degree and at least 3 years of Regulatory Affairs experience in the Medical device or Pharma sectors.

The ideal candidate will demonstrate strong communication skills, a solid understanding of global regulations, and proficiency in MS Office. Occasional travel is expected for this position.

Qualifications

• At least 3 years of increasing Regulatory Affairs experience in Medical device and/or Pharma.
• Solid working knowledge of domestic and global regulations.
• Computer proficiency with MS Office applications.

Responsibilities

• Execute regulatory strategy leading to successful registration and life‑cycle management.
• Review labeling, training, and promotional material.
• Support product and shipping release.

Skills

Regulatory Affairs experience

Knowledge of FDA regulations

MS Office proficiency

Strong communication skills

Education

Bachelor’s Degree

Job description

Description

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.

Essential Job Functions

• Review labeling, training, and promotional material
• Support product and shipping release
• Maintenance of FDA’s GUDID database
• Technical file update and reviews
• Review of External Standards
• Support business with government queries and registration documentation requirements
• Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions
• Support post market regulatory compliance activities for US/International product approvals
• Assist with the development and maintenance of regulatory affairs department procedures
• Comply with applicable FDA and international regulatory laws/standards
• Ensure relevant ISO and FDA Export requirements are met, as required
• Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
• Compiles all materials to support submissions, license renewal and annual registrations
• Keeps abreast of regulatory procedures and changes
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
• Customer Service Support
• Proactively drive activities to meet and/or exceed company objectives
• Maintain regulatory files/database and chronologies in good order
• Manage interactions with distributors, consultants, and/or partners
• Perform other related duties and responsibilities as assigned

Qualifications

• Bachelor’s Degree required
• At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience
• Solid working knowledge of relevant domestic and global regulations and guidance
• Exercise outstanding judgment in all areas of responsibility
• History of successful interactions with global regulatory authorities
• Computer proficient with web browser/internet search, MS Outlook, Word, Excel, Power Point; technical competence includes ability to learn new software and systems
• A combination of education and experience may be considered

Competencies

• Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry
• 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 communication skills with 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

Physical Requirements

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include close vision, ability to adjust focus, color code.

Mental Requirements

This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem‑solve; to make decisions; to analyze and interpret data; to multi‑task, re‑direct and handle numerous interruptions.

Other Requirements

Some travel, approximately 15%

Work Environment

The noise level in the work environment is usually quiet to moderate.

Equal Employment 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 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.