The-Regulatory-Quality Specialist is responsible for coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company.  Assist with internal audits, inspections and training records as needed.

Key Responsibilities include:

• Lead global regulatory registration effort.
• Assist with planning and preparing domestic and international regulatory submissions.
• Maintain global registrations.
• Maintain FDA establishment registration.
• Administer FDA Registration & Listing account.
• Obtain Certificates to Foreign Government (CFG) and Free Sale Certificates.
• Assist with maintaining medical device Technical Files.
• Maintain external documents (Standards, Guidance Documents).
• Assist with maintaining employee Quality related Training Records.
• Support, identify and collaborate on process improvement efforts.
• Additional duties and/or projects as assigned.

Skills & Experience Necessary:

• Minimum of an Associate's degree required. Bachelor's degree highly preferred.
• Possesses advanced knowledge of QMS (quality management systems) and regulations including ISO 13485, ISO 14971, FDA 21 CFR 820, EC MDR 2017/745, CA SOR 98/282, etc.
• Excellent written and verbal communication, interpersonal, and leadership skills.
• Demonstrated abilities to work independently and with cross-functional teams.
• Strong time management and organizational skills; Must be highly attentive to detail.
• Positive attitude and a team player.

No relocation is available.  Only local applicants will be considered.  

Compensation is $65,000 -$75,000 per year based on experience.

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