Specialist, Regulatory Science – Individual Contributor

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.