Regulatory Affairs Specialist

Regulatory, 510(k), PMA, FDA, Medical Device, Medical devices, Compliance, Regulatory affairs
Full Time
$115,000 - $150,000
Travel not required

Job Description

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:

  • Obtain product clearance in the U.S. and Canada. 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 Mid and Senior Level Regulatory Submissions Specialists report to the Director of Regulatory Affairs

Requirements:

  • MUST have experience preparing or authoring or working on or contributing to submissions for 501(k) and/or PMA and/or HDE for Class II and/or Class III devices
  • 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.

Benefits

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.

Dice Id : equest
Position Id : 6725658
Originally Posted : 1 month ago
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