Medical Device, Quality/Risk Management, Regulatory Compliance
4 Year Degree
Position Summary/ Objectives:
The Regulatory Affairs Specialist, Compliance and Labeling will be responsible for coordinating all tasks related to implementing a new private brand. They will work with individuals from Marketing, Purchasing, Quality Assurance, Materials Management, and Customers to plan, guide, and facilitate the life cycle of the project from when the distribution agreement is signed to product launch and any maintenance thereafter.
Essential Job Functions:
Maintain global label management and related regulatory support for Company’s projects.
Plan, coordinate, and implement activities for new private branding projects.
Oversee labeling activities for new product introductions and for updates of current product labeling.
Collaborate with internal departments, as well as customers for project planning and scheduling.
Work with Marketing, Customers, and Suppliers to create Labeling materials (Product labels, Instructions for Use, Boxes, Patient Information Leaflets and/or Marketing Literature).
Function as a Subject Matter Expert (SME) for global regulatory labeling requirements.
Ensure all labeling complies with country-specific regulations.
Provide regulatory guidance and updates to project teams during internal project meetings.
Prepare regulatory filings and change notifications associated with new or revised labeling as needed.
Review product labeling, including internal and external promotional material and marketing literature, for applicable regulatory compliance.
Prepare labeling information for specific distributor/customer requests to support global product registration.
Manage global databases and regulatory device listings (FDA, MDSS, EUDAMED ETC.)
Review and process complaints related to labeling.
Coordinate and support recall activities related to labeling errors.
Document and file Regulatory Status Determinations for assessment of labeling changes.
Ensure control and continuous improvement of CMI’s labeling program to meet business needs and regulatory requirements.
Write or update QS procedures, labeling specifications or work instructions related to the regulatory department.
Collaborate effectively with project teams to identify risks and risk mitigation strategies.
Train appropriate labeling and packaging team.
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.
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.
Assist with various special ad hoc projects and other duties as assigned
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.
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 2 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
Additional Salary Information: Health Insurance, Life Insurance, Vision, Dental, 401k, Paid Time Off, Bonus Eligible
Internal Number: 0002
About Collagen Matrix
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.