Specialist, Regulatory Science - Individual Contributor

We are offering a long term contract employment opportunity for a Specialist in Regulatory Science. This role is based in Mahwah, New Jersey and is primarily focused on supporting the manufacturing of orthopedic medical devices, particularly pertaining to the sterilization and cleanliness of these devices. The role involves a significant amount of collaboration and communication with internal operations and external suppliers, as well as compliance with cGMP/cGDP, safety, and regulatory requirements.

Key responsibilities:

• Author and execute protocols, while also generating final reports to assess the impact of manufacturing-related changes on cleanliness requirements for the medical devices.
• Collaborate with project owners to gather all necessary information for assessments.
• Manage the execution of microbiological and chemistry testing both internally and externally.
• Ensure compliance with cGMP/cGDP, safety guidelines, and regulatory requirements in all aspects of work.
• Handle the analysis and evaluation of materials and products at all stages of the development process.
• Maintain a strong focus on quality assurance and quality control duties as required.
• Utilize standard laboratory techniques, such as USP and ISO based testing methods, in daily operations.
• Maintain knowledge of scientific concepts, measures, and terminology, and apply specific laboratory protocols.
• Utilize Microsoft Office suites, including Word, Excel, Outlook, and PowerPoint, to efficiently execute tasks and communicate with team members.

• Knowledge of cGMP/cGDP required.

• Exceptional communication skills, both verbal and written, to effectively convey regulatory information

• Proficiency in Microsoft Office Suites including Word, Excel, Outlook, and PowerPoint

• Demonstrated experience in operations, specifically within a manufacturing environment

• Strong understanding of compliance and the ability to execute necessary compliance functions

• Experience in materials handling, with a focus on safety guidelines and OSHA standards

• Supervisory skills, with the ability to guide teams and ensure adherence to protocols

• Proficiency in Microsoft Office Suites to effectively manage and organize regulatory information

• Quality assurance and QA/QC skills, with the ability to ensure protocols and standards are met

• Knowledge of regulatory requirements, particularly in the medical device industry

• Experience in sterilization processes, specifically within orthopedic manufacturing

• Exceptional computer skills to effectively manage regulatory systems and databases

• Ability to work onsite, adhering to all safety guidelines and protocols.

• B.S. degree in Biological Sciences or related field with minimum of 5 years of Quality Assurance and/or Sterility Assurance experience preferred.