The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.
- Act as liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs - Develop new, and refine existing, systems that provide the necessary information for successful submission to global regulatory bodies - Help align engineering procedures and project outputs with regulatory requirements - Assist various Regulatory Affairs staff with technical assessment and writing of regulatory submissions and responses to regulatory agencies - Prepare regulatory submissions for new products, product changes, and re-registrations, as required - Perform and/or coordinate required assessments for change orders and facilitate approval - Provide product knowledge and training for Regulatory functional unit - Coordinate regulatory initiatives and drive to completion - Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision -Ability to understand the purpose of a Quality System, and to effectively and efficiently complete work within guidelines of the Cook Inc Quality System
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization. - Must strictly adhere to safety requirements. - Maintain regular and punctual attendance. - Must maintain company quality and quantity standards. - Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision. - Ability to remain calm and receptive in fast paced situations.
Physical Requirements/Work Environment
- Works under general office environmental conditions - Sitting for extended periods, utilizes close visual acuity for working with computers, etc. - Travel as required
-Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
***Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Employer will assist with relocation costs.
Internal Number: 2019-5976
About Cook Inc.
We are a privately held, Indiana-headquartered company with a global reach. Our roots are in minimally invasive medical devices and we are always expanding into new areas of treatment – cellular therapies, biologics, regenerative therapies, and more. We have also developed businesses that support the communities where we live and work, such as hospitality, transportation and real estate.
Our work environment focuses on bringing people together, fostering relationships that promote respect, inclusion, diversity, and equality in all of our interactions. These collaborative working relationships foster innovation and make Cook, our employees, and our communities stronger.