Regulatory Affairs Specialist
General Job Description:
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:
• Obtain product clearance in the U.S., Canada, Mexico and any other countries as needed. Determine regulatory requirements for changes/modifications made to 510(k) or PMA device(s), and/or new devices to be included in the 510(k) and PMA system.
• Prepare and file 510(k), PMA, HDE, annual report, PMA supplement, notification, etc. based on technical information provided by the project development team. Follow the 510(k) and PMA through to completion by tracking its review progress at FDA and coordinating any responses to FDA requests for further information.
• Conduct systematic audits of the company's quality systems in relation to requirements found in ISO 13485:2003, the FDA Quality System Regulations and any other applicable requirements. Facilitate the definition, assignment and closure of corrective actions. Report audit results and corrective action progress to management.
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.
Experience with preparing submissions for 501(k) and/or PMA and/or HDE
Experience determining regulatory requirements and status for new/proposed medical products
Experience dealing with the FDA and be familiar with FDA regulations, guidelines and requirements as well as other medical device-related regulations (GMP, QSR).
Conduct audits and ensure compliance in regards to quality systems for the FDA and ISO
Application Information & Contact (How to Apply)
Apply by e-mailing your resume to firstname.lastname@example.org
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