Sobre este puesto de Global Regulatory Affairs and Compliance Manager- Medical Devices en Jabil
How will you make an impact?
The Regulatory Affairs & Compliance Manager is responsible for developing, implementing, and maintaining regulatory affairs and quality system compliance programs to ensure continued compliance with applicable global regulations, standards, internal and customer requirements. This position provides regulatory affairs leadership and compliance oversight across manufacturing operations, supports regulatory inspections and external audits, and partners with cross-functional teams to ensure products and processes remain compliant throughout their lifecycle.
The role serves as a key liaison with regulatory authorities and certification bodies, while driving continuous improvement initiatives that strengthen the organization's compliance profile.
What will you do?
Regulatory Affairs:
Develop and execute regulatory strategies that support business objectives and product lifecycle management as applicable to a Contract Manufacturer Organization (CMO).
Ensure compliance with applicable global regulations, including FDA, ISO 13485, ANVISA, PMDA, and other international regulatory requirements, as applicable.
Maintain establishment registrations, globally.
Support customer regulatory requests.
Provide regulatory guidance for new product introductions, design changes, manufacturing transfers, and process changes.
Review regulatory documentation as required.
Maintain Drug Mater Files.
Assess regulatory impact of engineering changes and manufacturing modifications.
Compliance:
Ensure the Quality Management System remains compliant with applicable regulations and standards.
Develop, implement, and maintain regulatory compliance procedures and policies for the site.
Monitor compliance metrics and report key performance indicators to leadership.
Lead quality system compliance initiatives and continuous improvement projects.
Support Management Review activities by providing regulatory and compliance performance data.
Ensure effective implementation of corrective and preventive actions related to regulatory compliance.
Lead site readiness for regulatory inspections and certification audits.
Serve as primary regulatory representative during FDA inspections, certification body audits, and customer audits.
Coordinate responses to regulatory observations, audit findings, and other regulatory communications.
Track commitments and ensure timely completion of corrective actions.
Ensure effective implementation of the internal audit program and regulatory compliance assessments.
Identify regulatory compliance risks and develop mitigation strategies.
Promote a culture of compliance and continuous improvement.
Support harmonization and standardization of regulatory and quality system processes.
Support implementation of digital quality systems and regulatory technologies.
Lead or participate in cross-site compliance projects
Cross-Functional Leadership:
Partner with Quality, Operations, Engineering, Supply Chain, and other teams to ensure regulatory compliance throughout the product lifecycle within a CMO.
Provide regulatory guidance during product development, validation, technology transfers, and process improvements.
Lead or participate in cross-functional compliance projects.
Mentor personnel and provide regulatory training across the organization.
How will you get here?
Knowledge requirements:
Thorough knowledge of:
ISO 13485
FDA Quality Management System Regulation (21 CFR Part 820/QMSR)
Medical Device Submissions
ISO 14971
Global medical device regulatory requirements
Strong understanding of Quality Management Systems.
Experience with CAPA, Nonconforming Product, Complaint Handling, Risk Management, Change Control, Internal Audits.
Strong analytical and problem-solving abilities.
Excellent regulatory writing and technical documentation skills.
Effective project management and organizational skills.
Excellent verbal and written communication skills.
Ability to influence cross-functional teams without direct authority.
Proficiency with electronic Quality Management Systems (eQMS), document management systems, and Microsoft Office applications.
Experience and Education:
Education:
Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline.
Master's degree preferred.
Experience:
Minimum 3 years of experience in Regulatory Affairs within the medical device industry.
Minimum 6 years of experience in Quality Assurance, Quality Systems or Compliance within the medical device industry.
Minimum of 3 years of experience conducting audits in the medical device industry (ISO 13485, Lead Auditor certification preferred).
Minimum 3 years of leadership or management experience.
Experience supporting Health Authorities inspections and/or external audits.
Preferred Certifications:
Regulatory Affairs Certification (RAC)
ASQ Certified Quality Auditor (CQA)
ASQ Certified Quality Engineer (CQE)
Exemplar Global Lead Auditor (ISO 13485)
Lean Six Sigma Green Belt or Black Belt (preferred)
BENEFITS PACKAGE WITH JABIL
Competitive base salary
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&DJBL TA - Job Requisition Process Status, and Disability Insurance
Commuter Benefits
Employee Assistance Program
Pet Insurance
Adoption Assistance
Annual Merit Increases
Community Volunteer Opportunity
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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