Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
Overall Position Objectives:
An entry-level position that monitors international government regulations, legislations and laws affecting the company’s products, files regulatory submissions and assists project teams to obtain global approval for new or modified products.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, ISO, EN, MDR, MDD, OSHA, EPA, etc.).
Coordinate and prepare renewal of regulatory certificates, licenses and registrations. Including but not limited to FDA facility registrations and device listings, CE Certifications, Medical Device Licenses, TGA Conformity Assessment Certificates, EDQM Certificates, etc.
Support global regulatory submissions, registrations and filings. Duties include writing, formatting, compiling and maintaining supporting documentation/technical files for new products and product modifications.
Support the preparation of additional information or responses as requested by regulatory agencies.
Prepare technical information for specific distributor/customer requests to support global product registration.
Identify, obtain and maintain relevant guidance documents, international standards, or consensus standards and distribute or make available to appropriate departments.
Complete gap analysis to ensure continue compliance with updated regulations and standards and recommend changes to company quality system procedures.
Write or update QS procedures or SOPs related to the regulatory department.
Compile and maintain regulatory documentation databases or systems.
Review product labeling, including internal and external promotional material and marketing literature, for applicable regulatory compliance.
Document and file Regulatory Status Determinations for assessment of engineering change orders.
Identify, analyze and report Post Market Surveillance data.
Monitor and report existing and emerging zoonosis.
Identify, implement and monitor Corrective/Preventive Action Requests as related to the regulatory department.
Participate in internal or external audits.
Support electronic filing of Medical Device reports and Vigilance Reports
Supports data entry to the Global Unique Device Identification Database (GUDID)
Initiate, recommend, or provide solutions through designated channels.
Initiate action to correct or prevent the occurrence of any nonconformities relating to product, process and quality system.
Global Unique Device Identification Database (GUDID) Labeler Data Entry (LDE) User
Authorized access to FDA Electronic Submissions Gateway for filing electronic Medical Device Reports (eMDR)
Knowledge and Skills
The position requires the following skills:
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.
Education and Experience:
This position requires a bachelor’s degree or equivalent in the biological, life or health sciences or engineering with no experience necessary.
Internal Number: 1
About Collagen Matrix, Inc.
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.
Our two facilities are situated in New Jersey, USA. The Corporate Headquarters and Manufacturing site is located in Oakland and the second Manufacturing facility is located in Allendale. These locations provide ample manufacturing capacity to support upcoming new product launches and anticipated expansion.
The evolution of the company’s leadership, proprietary technologies, design capabilities, manufacturing expertise and product portfolio has established a solid foundation for continued growth.