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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Growing orthodontic lab looking for a Quality Specialist to perform document control and auditing tasks to maintain documentation and training materials involved with medical device manufacturing and regulatory compliance.
College degree preferred, but not required. Must have High school diploma or GED equivalency.
Experience in a manufacturing environment, preferred.
1- 3 years’ experience in teaching or industrial training, preferred.
Proof of eligibility to work in the United States by completing an I-9 form.
Ability to read, write, speak, and understand English.
Excellent communication skills: verbal and written.
Excellent attention to detail and organizational skills required.
Great people skills.
Ability to sit and/or stand for extended periods of time depending upon task being performed.
Excellent computer skills; advanced in MS Word, Excel, and PowerPoint.
Experience with Adobe and Photoshop, a plus.
Maintain training records, files, and logs.
Spell check, proofread, and/or cross-check documents to ensure accuracy and completeness.
Maintain overall document control structure within an electronic document management system.
Ability to explain/train new employees on company standards and procedures.
Ability to create training materials/curriculum per company standards and procedures.
Oversee training of regulatory related materials to staff.
Support development of system and process improvements that would enhance compliance to documentation/training requirements.
Maintain training website content manager.
Perform internal quality audits as requested.
Assist with regulatory audits as needed.
Assist in CAPA documentation, investigation, closure, and effectiveness checks.
Maintain records and revise documentation as needed per 21CFR 820.20 and ISO 13485/CMDCAS to ensure compliance with regulatory requirements.
Assist Director of Quality & Regulatory ensuring laboratory QA compliance (records, signatures as required, etc.)
Benefits Available Include
Medical and Dental Insurance (after 90 days)
Life and Short-term Disability Insurance (after 90 days)
Specialty Appliances is a full service orthodontic laboratory, producing more than 250 premier products. Since 1981, we have focused on developing and manufacturing top quality orthodontic appliances for children and adults. Our relentless commitment to first rate appliances sets us apart from other labs. Specialty is one of the very few US orthodontic laboratories to receive our ISO 13485 certifi...cation, ensuring the highest quality laboratory processes and products that your patients deserve.
Specialty Appliances is committed to research and development and always looking for effective ways to improve orthodontic treatment. This innovative approach has led to many laboratory inventions like the MiniScope® Herbst, AppleCore® Screws, ROC™ Crowns, Ratcheting Expansion Screw™, Rapid Molar Distalizers, Digital Positioners, Clear Image® Aligners and many others.