Title: Compliance Manager
Location: US-California-San Jose
Job Number: REG0007D
JOB SUMMARY:
The Compliance Manager is responsible for assisting in managing the development, implementation, and improvement of an effective quality system designed to meet appropriate WW Business, Corporate, Government, and International Standards for efficacy, safety, and quality. Assures programs are consistent in complying at a minimum with FDA 21 CFR Part 820 Quality System Regulation, FDA 21 CFR Part 803 Medical Device Reporting, FDA 21 CFR Part 806 Corrections and Removals, ISO 13485 QMS Medical Devices, ISO 9000 QMS and international regulations and standards for IVD and Medical Device products in both clinical and research applications as well as custom products. Works on complex problems where analysis of situations or data requires an evaluation of intangible, variable factors. Exercises judgment in developing methods, techniques, and evaluation criteria for obtaining results. Ensures that budgets and schedules meet BDB-IS targets or that changes are approved at appropriate levels. Directs and coordinates the Regulatory Compliance activities and departments through subordinates who exercise responsibility for results in terms of compliance, costs, methods and employees. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
DUTIES AND RESPONSIBILITIES:
1. Manages and coordinates the Regulatory Compliance Department and associates who exercise responsibility for results in terms of compliance, costs, methods, and employees. Areas of responsibility include Post Market Surveillance (Medical Device Reporting, Recalls and Field Actions), Customer Complaints, CAPA, Audit and QMS Training.
2. Establishes and delegates operational goals, objectives and assignments. Formulates and implements policies and procedures to carry out the BDB-IS quality goals in support of the BDX quality policy and quality system on a worldwide basis.
3. Develops and implements quality reporting systems and administers FDA, ISO 13485, ISO 9000, and International Regulations (e.g. MDD, IVDD, SFDA, Canadian and Japanese PAL) including audits and certification.
4. Maintains all site registrations with the FDA, international governments and ISO certifications, including product safety certification bodies.
5. Hosts external regulatory inspections in conjunction with the Director Regulatory Compliance. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management.
6. Oversees all MDR and worldwide vigilance reporting for applicable BDB products, including all Corrections and Removals, recall activities and field actions worldwide. Manages the Situation Analysis / Health Hazard Evaluation / Field Action committees.
7. Manages the customer complaint system within BDB-IS that includes timely submission of product related investigations, reports, documentation, and communication to BD customers and responsible BDB-IS and Corporate departments. Ensures all complaints are assessed for reportability to the FDA and all applicable worldwide governing bodies.
8. Manages the corrective and preventive action process and ensures effective reporting mechanisms are developed and followed for Management Review. Responsible for the CAPA system maintenance and training of all CAPA users.
9. Ensures adequate and effective auditing of BDB-IS quality systems and suppliers. Organizes audits on a timely basis to ensure compliance with appropriate standards and regulations for the development, manufacture, release, and support of all BDB-IS products.
10. Ensures the compilation of quality and compliance data for BDB-IS Management Review purposes.
11. Manages the BDB-IS Regulatory Compliance Training program, ensuring quality system training requirements are maintained. Responsible for maintenance of the C2C content for the BDB-IS site associates, including training on system use.
12. Develops and monitors budgets for capital expenditures, operating supplies, and labor. Provides justification for resource requirements to senior management.
13. Communicates project status, compliance progress, problems, and procedures across all applicable BDB-IS groups.
14. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, transfers, promotions, salary actions, and processes performance reviews on time.
15. Exercises responsibility for associate training, development, and motivating supervised associates.
16. Keeps abreast of the U.S. and non-U.S. regulations affecting own area of supervision/management and complies with those regulations. Initiates changes to BDB-IS practices and procedures to support compliance requirements. Communicates the need for compliance to members of own functional area. Brings regulatory compliance questions/issues to the attention of the next level of management.
17. Partners with other quality professionals to address recurring issues identified throughout the organization.
18. Performs all other duties and supports projects as assigned.
Qualifications:
Minimum Knowledge and Skills:
* FDA Quality Systems Regulations 21 CFR Part 820, ISO 13485 Quality Management Systems – Medical Devices, ISO 9001 Quality Management Systems, 21 CFR 809In VitroDiagnostic Products, 21 CFR 864 Hematology and Pathology Devices specifically Analyte Specific Reagents (ASRs) and 21 CFR 1040 Light Emitting Products (Lasers).
* International Regulations for Medical Devices andIn VitroDiagnostic Products, e.g. but not limited to: EU Medical Device Directive (MDD), EU IVD Directive (IVDD), Canada SOR/98-282 Medical Device Regulations, Japan Pharmaceutical Affairs Law (JPAL) Ordinances 135, 136, 169 and 237, Brazil ANVISA RDC 59/00 Medical Devices and RDC 167/04 and 686/98 IVD Products, and China SFDA Quality Management Systems.
* Medical Device Reporting Regulations 21 CFR Part 803, Medical Device Corrections and Removals Regulations 21 CFR Part 806, and worldwide applicable regulations and standards.
* ISO 14971 Risk Management.
* Effective oral and written communication skills targeted at all levels within the company. Including strong skills in interpersonal, collaborative team building, meeting facilitation and presentation.
* Effective financial management, planning, and organizational skills.
* Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.
* Project management utilizing analytical, technical, and problem solving skills. Able to perform multiple complex tasks/projects and prioritize workloads and activities.
* Extensive computer skills, e.g. word processing, data analysis and enterprise management systems.
* Ability to travel (International and Domestic) up to 30%.
Education and Experience:
· Requires a Bachelor's Degree in a related life science or engineering discipline and 10 years experience in Quality, Regulatory, or Operations of a Medical Device / IVD firm.
· Professional certification is an advantage (e.g., CQA, CQE, SQE, CQM, etc.)
Job: Regulatory Compliance