Medical Device Regulatory Compliance Lead en Jabil
Jabil · West Chester, Estados Unidos De América · Onsite
- Senior
- Oficina en West Chester
Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified Medical Device Regulatory Compliance Lead to work in our West Chester, PA site. As the Medical Device Regulatory Compliance Lead, you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will also drive internal audits and lead the preparation/readiness activities for external audits (Customer Audits, ISO Certification audits and Health Authorities Inspections). As required, you will support in the preparation of responses to identified observations from these audits. The qualified person will have the objective of maintaining high quality standards for the product manufacturing process in compliance with all applicable standards and regulatory requirements such as ISO 13485, 21 CFR 820 and ANVISA.
In this Role you will:
Be the Champion and subject matter expert for Regulatory Compliance programs.
Internal Audit Program management and execution.
Establish and execute an effective internal audit schedule for the sites.
Execute against established internal audit procedures.
External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all times.
Prepare and provide support to external audits: e.g. Certification Body, Ministry of Health country inspections, Customer audits for site.
Audit preparation activities (auditor logistics, front room/back-room arrangements, identifying/preparing SME’s, etc.).
Assess the risk and applicability of audit observations from other sites to determine impact on the site.
Schedule and manage mock inspections as part of External Inspection Readiness activities.
Provide timely information to support the audit/inspection process, including those that may be taking place at other sites / locations.
Provide daily inspection communications regarding potential non-conformities.
Support response preparation to any external inspection or other regulatory notification associated with site.
Participate in developing adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
Participate in developing adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
Drive compliance and improvement in internal audit metrics.
Ensure the quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
Execute compliance training program(s).
Responsible for proposing and execution of Quality System improvement opportunities.
Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
Perform 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
Willingness to travel to the Elmira, NY location 1 week per month.
Other duties as assigned
Job Qualifications
Knowledge, Education & Experience Requirements
Bachelor’s degree required (Technical area, Business or Life Sciences) preferred.
At least five (5) years of experience with medical device operation.
Experience in External Audit readiness and management.
Supervisory experience, preferably QA exempt personnel
Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
Lead Auditor or Lead Assessor Certification, highly preferred.
Experience in root cause analysis and CAPA is required
Expertise in Quality System Regulations, with the ability to relate these to real life issues.
Ability to make decisions which will effectively support the business and company policies.
Required proven leadership, teamwork, initiative, and assertiveness skills.
Excellent communication skills, able to quickly build credibility within the Regulatory Compliance team.
Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
Benefits you will receive while working with Jabil:
Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
401K match
Employee Stock Purchase Plan
Paid Time Off
Tuition Reimbursement
Life, AD&D, and Disability Insurance
Commuter Benefits
Employee Assistance Program
Pet Insurance
Adoption Assistance
Annual Merit Increases
Community Volunteer Opportunities
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
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 identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
Accessibility Accommodation
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [email protected] or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
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