Regulatory/Clinical Affairs Specialist

Company: Global medical company specializing in the development and commercialization of innovative medical technologies with the mission to improve patient outcomes by providing safe, effective, and reliable solutions to healthcare professionals around the world.

• Hybrid Work Environment: 3 days onsite, 2 days work from home
• Must have a Green Card or be a US Citizens (no sponsorships or corp-to-corp considered)
• Location: Sandy Springs, GA

Job Summary: Make a difference in the lives of patients as a Regulatory/Clinical Affairs Specialist at an outstanding global medical company. You will be responsible for ensuring compliance with regulatory requirements in the areas of product development, product registrations, and post-market surveillance. You will work closely with cross-functional teams, including R&D, quality assurance, and manufacturing, to help bring innovative medical devices to market that improve patient outcomes.

Key Responsibilities:

• Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to ensure timely completion of regulatory submissions and clinical trials.
• Develop and implement regulatory strategies for medical devices, including preparation and submission of regulatory filings.
• Support product development by providing regulatory guidance and ensuring compliance with applicable regulations and standards.
• Work closely with cross-functional design change teams to assess impact to product registrations.
• Participate in internal and external audits, and provide support to ensure compliance with applicable regulations and standards.
• Prepare and maintain regulatory documentation, including technical files, labeling, and product registration.
• Maintain knowledge of current regulatory requirements and standards, and communicate changes to relevant stakeholders.

Qualifications:

• 4+ years of experience in regulatory affairs within the medical industry.
• Experience with registration and commercialization of medical devices.
• Bachelor's or Master's degree in life sciences, engineering, or related field.
• Ability to work independently and in a team environment.
• Knowledge of FDA regulations and international regulatory requirements.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.

Benefits:

• Highly Competitive salary
• Opportunities for growth and advancement within the company
• Comprehensive benefits package