Global Regulatory Affairs and Compliance Manager- Medical Devices

Jabil; Albuquerque (NM); Sur place; USD 110 000 - 170 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

Medical, Dental, Vision Insurance

401K match

Employee Stock Purchase Plan

Paid Time Off

Tuition Reimbursement

Commuter Benefits

Employee Assistance Program

Pet Insurance

Adoption Assistance

Annual Merit Increases

Résumé du poste

Jabil seeks a Regulatory Affairs & Compliance Manager to lead strategies ensuring FDA and ISO 13485 compliance across manufacturing operations. You will coordinate regulatory submissions, guide design changes, and partner with Quality, Operations, and Engineering to drive a culture of compliance.

You will act as primary regulatory liaison during FDA inspections and external audits, delivering training and mentoring to teams while supporting process improvements and digital quality initiatives.

Qualifications

• Bachelor's degree in a technical field; Master’s preferred.
• Minimum 3 years of Regulatory Affairs experience in medical devices.
• Minimum 6 years of Quality Assurance/Quality Systems experience in medical devices.
• Minimum 3 years of leading audits (ISO 13485) or regulatory inspections.

Responsabilités

• Develop regulatory strategies to support product lifecycle for a CMO.
• Ensure compliance with FDA, ISO 13485, and international regulations.
• Lead regulatory inspections and customer/regulatory audits; respond to findings.

Connaissances

Regulatory affairs

Quality management

Regulatory writing

Cross-functional leadership

Project management

Communication

Formation

Bachelor's degree in a technical field

Master's degree preferred

Outils

eQMS

Document management

MS Office

Description du poste

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world’s top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

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

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 [e-mail] 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.

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.

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