Director or Manager of Regulatory and Clinical Affairs
Summary: Plans and conducts scientific, regulatory and clinical affairs activities in support of OptiScanner regulatory clearance in US and EU. Directly responsible writing for all regulatory submissions including all clinical / benchtop study protocols and reports required for the submission. Manages all external regulatory and clinical consultants within the established department budget to accomplish this. The position requires the ability to synthesize a breadth of disciplines including engineering, regulatory affairs, medicine and clinical practice. It requires the application of theoretical knowledge as well as analytical, strategic, and empirical skills to advance OptiScan technologies.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Manage 510(k) and Technical File Regulatory Submissions
- Manage all external clinical and regulatory consultant contributors
- Develop regulatory and clinical strategies and implementation plans for the preparation and submission of new products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Generate and compile regulatory submission materials and responses to deficiencies in submissions, especially related to clinical and benchtop data, and product labeling
- Develop and maintain all product labeling pulling in appropriate stakeholders when needed
- Analyze, interpret and develop clinical study reports
- Participate in the planning, execution and analysis of R&D, benchtop, and clinical experimentation and data
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Execute product testing for biocompatibility, immunotoxicology, cleaning, disinfection and sterilization validations, and other regulatory-required testing
- Create materials for review by OptiScan’s Clinical Advisory Board and coordinate / facilitate these meetings as required
- Establish schemes to leverage, for maximum clinical and commercial value, future versions of the OptiScanner (i.e., multiple analytes: glucose, lactate and hemoglobin and ScvO2)
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Evaluate design and / or process changes in context with risk and hazards analysis specific to the device and the software as well as FMEA, DFMEA and PFMEA as appropriate
- Contribute to post-marketing surveillance plans including product performance, adverse events, improvements to patient safety, and tracking post-market commitments
- Keep track of changing regulations, interpret their content, and ensure company compliance
- Interface with regulatory agencies; support audits and inspections
- Responsible for IRB approvals including development and approval of clinical protocols, and IDE approvals (if required)
- Primary Regulatory / Clinical Affairs project lead on all product development projects
- Comply with Company’s Quality System.
- Perform any other duties assigned by management.
Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:
- 5 or more years’ experience in an IVD company in a scientific and or regulatory affairs position with increasing responsibility.
- Product experience with a plastic disposable a plus (Class II or III). Capital equipment experience also preferred.
- Fluency in CLSI and CLIA
- Experience dealing directly with the Division of Chemistry and Toxicology as well as Notified Bodies (personal interaction highly preferred).
- Ability to read and absorb as well as generate and convey complex scientific issues to a wide audience including medical doctors, nurse clinicians, engineers, statisticians, regulatory bodies and senior management.
- In depth understanding of blood chemistry is a must.
- Specialty experience in the ICU environment is preferred.
- Hands-on experience authoring scientific publications and reports (clinical reports, data analysis, scientific protocols and reports).
- Ability to handle advanced mathematical concepts and detailed technical requirements.
- Practical team experience as a Regulatory Specialist covering all phases of development from concept to requirements, design, validation, release, maintenance and obsolescence of a product.
- Practical knowledge in applied statistics (ANOVA, t test, SPC, sample size calculation, process capability, MARD, CV).
- Superior written and oral communication skills are a must.
- Excellent knowledge of Microsoft Office Applications (Project, Power Point, Excel, Word).
- Ability to work quickly and with a wide variety of individuals, as a team member, and to juggle more than one task at a time as a manager.
- Knowledge of FDA Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and ISO 13485-2012 is required
MA/MS/PhD – Chemistry, Biochemistry, Medicine, Biology or related field from an A school.
The Scientific and Regulatory Affairs Manager will provide specific and focused direction and oversight to a wide range of scientific and regulatory affairs consultants including regulatory legal counsel as required.