Please note I have direct access to the Hiring Regulatory Affairs Manager on this position.
The leading Global Biotech Company in its niche is looking for a Sr. Regulatory Affairs Specialist. The company has been in business for 50+ years, is publicly traded, has 7+K employees, has $5.2B in revenues (14% increase over FY 2017), $108 million in profits (42% increase over FY 2017), has 750 product patents, released 4 new products in 2017 and is an active philanthropic institution.
The Sr. Regulatory Submissions Affairs Specialist will be responsible supporting and managing a medical device manufacturer regulated by the FDA in the United States and similar bodies in other countries (Asia, South America, Canada). The Sr. Regulatory Affairs Specialist will ensure 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) and CE Mark products. The Sr. Regulatory Affairs Specialist will:
The Regulatory Submissions Specialists report to the Regulatory Affairs Manager
Company offers a comprehensive benefits package including: medical, dental, and vision coverage for employees; vacation and paid company holidays; 6% matching 401K; 6% pension contribution, flexible spending plans, tuition reimbursement and a casual work environment.
Must have 5+ years’ experience determining regulatory requirements and status for new/proposed medical devices, pharmaceuticals and/or biotech products
Experience preparing submissions for 501(k)
Experience interacting with the FDA and be familiar with FDA regulations, guidelines and requirements
The following are only a Plus (NOT mandatory):
Any experience preparing submissions for CE Mark products, IDE’s, IND’s, NDA’s and ANDA’s
Compliance with United States’ Federal Code of Regulations for medical devices, European Economic Community: Council Directive and Health Canada: Medical Devices Regulations
Any experience with medical device regulations such as: 21 CFR 820, ISO 13485, ISO 62304, ISO 60601-1
Any experience or knowledge of pharmaceutical and/or biologic regulations and standards would be a plus
BS/MS and/or Regulatory Affairs Certification
Hermosa Beach, CA, 90254