Quality and Regulatory Affairs Associate
Penta Medical has the only cold laser therapy device that's as effective as clinical units, and the most advanced remote patient monitoring system currently available. Our products are used by top professional sports teams across the US, as well as leading orthopedic surgeons in SF and NYC.
As a Regulatory Affairs Associate, you will work in the day-to-day issues associated with regulatory affairs, and assist in the preparation of domestic and international regulatory submissions and keep abreast of ongoing changes in regulatory and compliance policies and procedures.
- Assist in the writing, review, and preparation of CTD compliant submissions and regulatory filings related to Medical Devices and Electronic Health Records to Health Canada, EU, US, and other regulatory agencies.
- Be responsible to provide input for various regulatory affairs projects, within specified time frames, ensuring accurate content, and quality control of each project.
- Follow emergence of new regulatory requirements and their impact on regulatory projects.
- Assist in the writing, maintenance and review of medical device and medical software reimbursement supplier contracts.
Qualifications and Experience:
- Minimum B.Sc. (advanced university Science degree in Pharmacology or related discipline preferred)
- Good technical writing skills and the ability to review and critique safety, efficacy, and quality.
- Excellent interpersonal skill and organizational, time management, and communication skills are essential.
- Computer literacy in Microsoft Office and Adobe Acrobat