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Regulatory Compliance Site Lead
vor 2 Wochen
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
Overall responsibilities
The Regulatory Compliance Site Lead supports effective implementation of the business wide compliance program that meets requirements for the medical device business. This position partners with other Regulatory Compliance leaders to ensure audit readiness and overall compliance through internal audit process and supplier audit process. Regulatory Compliance Site Lead collaborates with different partners to further refine short
- and long-term compliance objectives. This role provides Quality System Compliance support to the assigned site(s).
This includes the procedures and records required for the development, deployment, and maintenance of quality system processes to assure the ongoing compliance with MDSAP, ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
Position duties and responsibilities
- Responsible for ensuring compliance with all local, national, international and company regulations, policies, and procedures
- Conducts and leads Internal Audit as per Internal Audit schedule
- Supports Compliance improvements, which result from audits, Quality Board Issues and other system indicators
- Seeks opportunities to work with the other site compliance specialists to ensure consistent systems across the organization
- As Jabil Regulatory & Compliance representative, in close collaboration with site management, coordinates on a continuous basis, Inspection Readiness to prepare the site for external audit announced or unannounced.
- Supports proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools
- Trains and maintains users on the Audit system “EtQ” - Act as site system Audit module support
- Provides Front Room/ Back Room support during external audits
- Establishes and maintains regulatory inspection readiness plans for assigned sites
- Supports external audits and assessments that take place on Jabil sites and serves as the Subject Matter Expert for the Internal Audit process and Supplier Audit process
- If necessary, assists other facilities during external audit preparation and external audit execution
- Performs all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements
Education Requirements:
- At least Bachelor’s degree in Science, Engineering, Quality or another technical field
- Equivalent degree and/or adequate associated work experience is acceptable
- Lead Auditor qualifications are recommended
Further Education:
- Knowledge of Quality Systems (21 CFR 820/ISO 13485/ISO 9001) within a regulated environment
**Experience**:
- At least 4 to 6 years working experience in a regulated industry
- At least 1-year experience in a quality and/or compliance function
- Experience in performing audits is recommended
Interpersonal skills / characteristics:
- High Attention to Detail
- Ability to make complex issues simple
- Excellent Communication Skills (written & oral)
- Team Player
- Excellent time management
- Focus on achievement and delivery of results
- Active Listener
Other requirements:
- Available to travel to other sites
- Fluent Business English and French
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
