Regulatory Affairs Specialist

Position Summary/ Objectives

The Regulatory Specialist will be responsible for filing regulatory submissions and assisting project teams to obtain global approval for new or modified products.

Essential Job Functions

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, MDR, MDD, ISO, EN etc.).
• Coordinate, support, and author clear and concise regulatory filings for both domestic and international product registrations. Duties include writing, formatting, compiling and maintaining supporting documentation/technical files for new products and product modifications.
• Coordinate, support, and author clear and concise regulatory responses to requests for additional information by regulatory agencies.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review.
• Prepare technical information for specific distributor/customer requests to support global product registration.
• Collaborate effectively with project teams, peers, and customers to identify solutions with regards to regulatory strategies.
• Collaborate effectively with project teams to identify risks and risk mitigation strategies.
• Identify, obtain and maintain relevant guidance documents, international standards, or consensus standards and distribute or make available to appropriate departments.
• Complete Regulatory Status Determinations for assessment of engineering change orders.
• Complete gap analysis to ensure continued compliance with updated regulations and standards and recommend changes to company quality system procedures.
• Write or update procedures or work instructions related to the regulatory department.
• Review product labeling, including internal and external promotional material and marketing literature, for applicable regulatory compliance.
• Identify, analyze and report Post Market Surveillance data.
• Identify, implement and monitor Corrective/Preventive Action Requests as related to the regulatory department.

Education, Experience And Certification

• Ability to follow written and oral instructions with minimum supervision.
• Good communication skills, both verbal and written reports.
• Good organizational ability and strong attention to detail.
• Ability to utilize computer application packages, such as MS Word, Excel, and Adobe.
• Bachelor’s Degree or equivalent with a minimum of 3 years’ experience in Regulatory Affairs.
• Experience in a medical device or science related field is a plus.
• Possess a working knowledge of State and Federal Law
• Familiar with regulatory requirements for medical devices, such as FDA CFR 820, ISO13485, MDD, EU, MDR, CMDR, etc.

Since our inception in 1997, Collagen Matrix has been awarded significant grant money for the research and development of collagen based matrix products. We have expanded into two facilities with nearly 200 employees and have commercialized over 50 medical devices for our five business units – Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair. Our products are now distributed around the world via a substantial global distribution network.

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