The Senior Manager, Regulatory Compliance will be responsible for implementation, maintenance and continues improvement of regulatory compliance activities with a focus on CAPA execution and management of the internal, external and customer audit programs. Develop and implement strategies, processes and procedures to manage this activities. Ensure timelines preparation of scientifically valid and appropriate evidence to be used in quality records. Lead groups to translate regulatory requirements into plans that are executable in a timely manner. This is a hands on role and will require a mastery of highly technical scientific instrumentation, microfluidics and reagents including the process and procedures necessary to product them.
Implement and maintain a compliant and efficient CAPA system
Ensure a rapid escalation and resolution of customer complaints
Chair regular meetings to address quality issues and CAPA’s for rapid resolution and visibility across the Company
Oversee and perform internal, external and customer audits as per audit plan for identification of opportunities for continuous improvement of the Quality System. Ensure timely process, closure and effectiveness check of audit observations
Participate in Design Control activities to ensure documentation is completed as per requirements to ensure compliance and release of high quality product to market
Participate in Risk Management activities to ensure that risk is appropriately identified, mitigated and documented across the organization
Participate in the identification, implementation and validation of a QMS appropriate for the organization
In conjunction with executive management and regulatory affairs , develop strategic and tactical initiatives to deliver our future regulatory strategy
Execute the duties of the position such that the focus is largely proactive versus reactive.
Deliver superior compensation, benefits and opportunities for career growth
Engage you in a dynamic and rewarding company culture
Support you in your ongoing development and contribution both as an employee and a person
Value your contribution and enlist your feedback
Host excellent company-wide events multiple times a year
Offer onsite yoga classes, massages, randomly free and good food, friendly greetings, gym equipment and, seriously, a lot more
At least 12 years of hands on experience working in quality, in a regulated environment.
Technical Degree (BS or higher) in an engineering or science discipline with hands on experience creating quality system procedures which comply with ISO, FDA and European standards
Hands on experience with ISO 9001, ISO 13485, FDA QSR, CE directives such as Machinery Directive, Medical Device Directive and In Vitro Diagnostic Directive.
Hand on auditing experience including internal and external audits
Experience with managing Corrective and Preventive Action programs
Hands on experience with Design Control and Risk Management
The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced
Experience with diagnostics products a plus as well as front or back office experience in regulatory compliance inspections.
Ideally, the candidate will have worked with paper document based as well as electronic systems for Quality Documentation.
Knowledge of product standards such as IEC, RoHS, WEEE and others desired.