Please note I have direct access to the Hiring Director of Regulatory Affairs.
An International, successful, extremely profitable and the largest global privately held medical device Company is looking for a Sr. and a Jr. Regulatory Affairs Specialist. The company is privately held, has been in business for 50+ years, is very profitable and has never laid-off an employee.
The Sr. and Jr. 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 Sr. and Jr. Regulatory Submissions Specialists in this position ensures that the company complies with the United States Federal Code of Regulations for medical devices, the Mexican Ministry of Health requirements and Health Canada's Canadian Medical Devices Conformity Assessment System (CMDCAS) quality system under ISO 13485:2003 requirements.
The Sr. and Jr. Regulatory Submissions Specialists will:
The Sr. and Jr. Regulatory Submissions Specialists report to the Director of Regulatory Affairs
The company offers full benefits (PPO & HMO) including dental and vision, matching 401K, 3 weeks of vacation, paid sick days, Short and Long-Term Disability, Life Insurance, Tuition reimbursement, casual dress and flexible work hours that all start upon employment.
Hermosa Beach, CA, 90254