Senior Compliance Specialist
The Senior Compliance Specialist is responsible for developing, maintaining, and evaluating the Quality Management System (QMS) processes to ensure compliance with FDA regulations, GMP/QSR, ISO 13485, EU Medical Device Directives and other applicable quality system regulatory standards. Responsibilities include conducting quality audits to identify potential regulatory risks associated with non-compliances, as well as, supporting the management of third party inspections.
The Senior Compliance Specialist provides guidance to assist functional groups in the development, implementation and maintenance of the Quality Management System to ensure the organization functions effectively and consistently and ensure a high level of compliance in order to achieve the company's goals, objectives and policies, as well as, satisfy customer requirements.
- Provide quality systems compliance support and guidance in order to maintain compliance with all FDA, and other U.S., and international regulatory requirements as applicable, specifically in the Europe region.
- Conduct routine and directed audits, as assigned, to assure compliance with FDA regulations, international standards and requirements, local SOP's and corporate policies/procedures
- Provide quality compliance consultation, training and mentoring
- Provide guidance and assistance in compliance remediation projects
- Participate in preparation and coordination associated with corporate, FDA, and other international regulatory agency audits
- Provides guidance and direction to manufacturing sites in the development of corrective action plans including corrections, corrective actions, preventive actions and effectiveness checks to address audit findings
- Support management development of corporate policies, procedures and guidelines as assigned to support continuous improvement programs
EDUCATION, EXPERIENCE AND SKILLS:
- BS Degree in technical or scientific field or equivalent work experience
- 3-5 years of experience in medical device industry.
- Previous experience in delivering Quality System related training e.g. CAPA, Process Validation
- Demonstrated compliance fluency in QSR/GMP, ISO and other regulations
- Excellent written and verbal ability with attention to detail
- Strong organizational skills
- Team player and ability to serve on project teams, as needed
- General knowledge of Word, Excel, and PowerPoint
- Flexibility regarding travel is necessary, minimum 50% travel required
For further information please contact BImi Felix on 091730022 /
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