Regulatory Coordinator | On-site, Indianapolis, IN

Job Description

Job Description

About Us 

Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.

Driven by our commitment to supply high-quality medical devices, our team works to deliver best in class products to over 60 countries worldwide. 

Our Culture 

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic self. 

We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view.

Job Overview:

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:

• 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

Education/Experience:

• Bachelor’s degree in quality, risk management or related field.
• Must be able to speak, read and write English.
• 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 experience preferred. 

Skills & Competencies:

• 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

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.

Primarily an in-office role based out of Indianapolis with the flexibility to work remotely one day per week after successful completion of training.

Benefits: 

We are passionate about the well-being of others and that begins with caring for our people. 

????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...