Regulatory Coordinator

About the role

Primary responsibility is assisting with regulatory activities pertaining to distribution of products in the US market. Assist with generating and maintaining documentation required to allow products to be marketed domestically as well as to assist with maintaining compliance with QMS regulations.

Responsibilities

• Aid in maintaining complaint documentation and related activities
• Maintain documentation for internal & external audits
• Provide SOP training and maintain training matrix
• Aid the Regulatory Affairs Manager with regulatory activities

Requirements

• Bachelor’s degree in quality, risk management or related field
• Must be able to speak, read and write English
• In-depth understanding and experience with US FDA, and ISO Regulatory requirements
• Ability to work independently and cope with changing priorities, and to prioritize workload to meet datelines
• 3+ Years of relevant experience

Qualifications

• Technical or software proficiencies required: Competency in MSWord, Adobe Acrobat and Excel

Skills & Competencies

• Work independently, work and maintain priority in a timely manner

Physical & Work Environment Requirements

• Must be able to sit, stand and/or walk for extended periods of time
• Must be able to lift 25 lbs

Benefits

• Competitive salary
• Multiple opportunities to be challenged and step up your career in a fast-growth company
• 401k
• Paid Time Off and holidays
• Medical, dental, and vision benefits