Regulatory Coordinator

Engineered Medical Syst • Indianapolis, IN

3d • Onsite

About The Position

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.

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.
• Years of experience necessary for the role: 3+ Years
• Key skills needed: Work independently, work and maintain priority in a timely manner.
• Technical or software proficiencies required: Competency in MSWord, Adobe Acrobat and Excel
• Must be able to sit, stand and/or walk for extended periods of time. Must be able to lift 25 lbs.

Responsibilities

• Assist with Maintaining Complaint Documentation and Related Activities
• Maintain Documentation for Internal & External Audits
• Providing SOP Training and maintaining training matrix
• Assist with Regulatory Affairs Manager with Regulatory Activities

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
• 👀Much more...

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees