Please note I have direct access to the Hiring Director on this position.
Note: Until the Covid-19 virus is contained, all interviews will be performed via phone and/or video and all work will be performed remotely.
This is an outstanding opportunity that will allow a Regulatory Affairs Specialist to expand their experience by working with new cutting-edge devices and work for a Director and company that encourages career growth.
Company will transfer Visas if necessary
Company will provide full relocation assistance
An International, successful, extremely profitable and the largest global privately held software/hardware Company in its technology niche is looking for a Mid and a Senior Level Regulatory Affair Specialist. The company is privately held, has been in business for 65+ years, has $1+ Billion in revenue, has 5K+ global employees, is extremely profitable and has never laid-off an employee.
The Mid and Senior Level Regulatory Submissions Specialists will be responsible supporting and managing a medical device manufacturer regulated by the FDA in the United States and similar bodies in other countries. In order to market and sell medical device products, the company must comply with all applicable regulations in each country (globally) in which the products are sold. The Regulatory Submissions Specialists in this position ensures that the company complies with the United States Federal Code of Regulations for medical devices and Health Canada's Canadian Medical Devices Conformity Assessment System (CMDCAS) quality system under ISO 13485:2003 requirements.
The Regulatory Submissions Specialists will:
The Mid and Senior Level Regulatory Submissions Specialists report to the Director of Regulatory Affairs
The company offers full benefits matching 401K (6%), 3 weeks of vacation, 10 paid holidays, PPO & HMO, Dental and Vision, paid sick days, Life, STD, LTD & LTC Insurance, Tuition reimbursement, Fitness reimbursement, casual dress and flexible work hours that all start upon employment.