Have you worked as a Regulatory Affairs Specialist for Medical Device or Pharmaceutical company? We have an opening for a Regulatory Affairs Specialist. in Metro Atlanta (Norcross) offering a hybrid work schedule!

This position provides regulatory support to ensure compliance with FDA and other agency regulations in the Americas, which is defined as the United States, Latin America, and Canada. Under the supervision of the Regulatory Affairs Manager, you'll be responsible for:

• Definition and execution of product regulatory requirements and strategy in the region, with emphasis on United States
• Review of labelling and promotional materials
• Regulatory support of internal customers, including R&D, Operations and Commercial functions

KEY ACCOUNTABILITIES INCLUDE:

• Determine appropriate regulatory requirements and filing strategies for the release of new and/or modified medical devices and pharmaceutical products
• Prepare and submit regulatory submissions (e.g., 510(k), NDA supplements, Medical Device License Applications) and internal documentation for medical devices to health authorities in the Americas, including FDA, Health Canada, and LatAm regulators
• Direct interaction with FDA during submission review process
• Active team member during product development to provide guidance on regulatory requirements
• Assist in handling routine responses to data and information requests from regulatory agencies and internal departments
• Assist in the development and review of product labelling and promotional materials for compliance with medical device regulations
• Serve as strategic regulatory partner to the commercial team both pre and post approval activities

QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), engineering, or medical field preferred.
• 2+ years experience in Regulatory Affairs role with medical devices and/or pharmaceuticals; experience in direct interaction with US FDA required.
• Working knowledge of the healthcare industry, quality systems, promotional compliance and governing regulations.

• Strong communication skills (written and verbal) necessary in order to regularly interact with internal contacts, regulatory agencies, researchers, and customers.
• Critical and analytical thinking.
• Strong organizational skills and attention to detail.
• Basic computer skills, including Microsoft Office Suite

Job Type: Full-time

Salary: $81,851.00 - $86,785.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
Employees are required to be vaccinated against COVID-19

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs: 2 years (Required)

Work Location: Hybrid remote in Peachtree Corners, GA 30092

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