Director Of Regulatory Affairs & Quality Assurance

Our client, an innovative, start-up medical device company, whose device, focuses on the prevention and treatment of a side effect from anti-cancer treatments known as Oral Mucositis, is seeking an experienced Director ofRegulatory Affairs & Quality Assurance, to join their winning team.

Our candidate of choice will have a strong regulatory background and knowledge of US and international regulations and submissions, as well as strong experience with FDA Audits. The primary focus of this role is supporting, maintaining and improving the Quality Management System (QMS) and QMS certifications with additional focus on supporting medical device regulatory submissions, registrations, permits, licenses, clearances and approvals for US and  global market entry.

KEY RESPONSIBILITIES:

• Evaluating current QMS, Developing and implementing additional quality management systems SOP’s, etc
• The candidate will direct and oversee the research for applicable FDA, ISO, EU MDR, UKCA, Trade Compliance, ASTM, and other applicable regulations and standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements
• Ensuring compliance with USA and international regulations and submissions
• Preparing and managing regulatory submissions, including future 510(k) applications, PMA supplements, and CE Marking
• Conducting internal audits and supplier audits
• Managing the CAPA system and correspondence with the FDA
• Leading FDA inspections and responding to FDA observations
• Providing regulatory guidance to cross-functional teams
• Developing and delivering training on QMS /quality systems and regulatory topics as needed 
• The QA/RA Director shall ensure continuous visibility over the development and promulgation of medical device legal and regulatory enactments, identify company and product improvements or activities necessary to ensure compliance, and ensure that the company establishes controls and/or completes necessary activities to ensure compliance; reviews future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, PV, adverse event and corrective action reporting, translation, product standards, post market surveillance, and all other requirements necessary to support export & import, sales, distribution and market entry in all distribution markets.

KEY REQUIREMENTS:

• The ideal candidate will have a strong regulatory background and knowledge of international regulations and submissions, as well as strong experience with FDA Audits
• Strategic planning to ensure QA/RA systems and processes remain current and compliant
• 5-7+ years of experience in the Medical Device industry
• Experience managing/implementing quality management systems
• Experience conducting internal audits and supplier audits
• Strong communication skills
• Ability to work in a fast-paced environment
• Diploma, certificate or other formal qualification awarded with a university degree plus minimum of 4 years professional experience in Regulatory Affairs or QMS related to medical devices

WE OFFER:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance
• Paid time off-10 paid holidays per year, paid time off (PTO) for vacation, sick, or personal use
• Flexible work locations options / remote
• Leveraged performance-based bonus opportunities

Please apply today to be one of the first people considered for this position!

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