Quality & Regulatory Compliance Manager - Medical Devices
$85 - $90 per hourBEPC INC
Job Description
Job Description
BEPC is actively looking for Compliance Manager, in Mountain View, CA area!
W2 Contract – 15 months with possible extensions!
Benefits include medical, dental, vision, and life insurance
Pay Rate: $85.00 - $90.00/hour - Determined based on experience (Paid Weekly)
Work Model: Candidates must currently reside in or within commuting distance of the Mountain View, CA area, as this is a hybrid role requiring 2–3 days onsite per week.
Note : This is a W2 only role — C2C, C2H will not be considered
Summary of the Role:
BEPC is seeking a highly motivated Compliance Manager to join our client’s site in Mountain View, California. This role will support internal audit leadership, regulatory compliance activities, inspection readiness, and cross-functional collaboration across Local Operating Companies (LOCs) and Distribution Centers (DCs) within the EMEA region. The position is responsible for ensuring compliance with applicable regulatory requirements, quality system standards, and internal policies while proactively identifying compliance risks and supporting regulatory readiness, patient safety, and sustainable business operations. Success in this role also requires hands-on medical device compliance experience, including MDSAP, Notified Body interactions, current FDA QMSR requirements, and the ability to build and strengthen a proactive Quality Culture in partnership with site and functional leadership.
Summary of Duties and Responsibilities:
- Conduct and review internal audits in accordance with the Internal Audit Schedule.
- Lead the development and scheduling of regional internal audits and support audit response activities.
- Provide regulatory compliance expertise by assessing gaps identified through the EMEA LOC/DC Inspection Readiness Program.
- Identify, assess, and communicate proactive compliance risks ("Find It, Fix It") to regional leadership to support preventative compliance initiatives.
- Build and strengthen a proactive Quality Culture by partnering with site and functional leaders to develop, implement, and sustain compliance programs beyond checklist-based audit execution.
- Partner with Regulatory Affairs, Quality, Commercial, and Supply Chain teams to support compliant product distribution and lifecycle activities.
- Escalate emerging compliance issues, risks, and trends to management through data analysis and reporting.
- Manage regional LOC licenses across the EMEA region.
- Collaborate closely with the regional Regulatory Compliance team to support regional compliance objectives.
Main Qualifications:
- Education : Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, or a related discipline.
- Experience : 6–8 years of progressive experience in Regulatory Compliance, Quality, or a related function within a regulated industry.
- Strong experience serving as a Lead Internal Auditor.
- Hands-on MDSAP audit and inspection experience within the medical device industry.
- Direct experience working with Notified Bodies, preferably BSI and/or TÜV, including audit preparation, participation, and response activities.
- Current knowledge and practical experience with FDA Quality Management System Regulation (QMSR), including the transition from legacy Quality System Regulation (QSR) requirements.
- Demonstrated experience building and strengthening Quality Culture through proactive compliance program development and integration with site and functional leadership.
- Strong knowledge of regulatory and compliance requirements across EMEA markets.
- Experience supporting audits, inspections, and leading compliance assessments.
- Ability to manage complex compliance initiatives involving multiple countries and cross-functional stakeholders.
- English language proficiency required.
- Ability to travel moderately throughout the EMEA region (Europe, Middle East, and Africa).
Preferred Qualifications:
- Advanced degree in a scientific, regulatory, or business-related field.
- Familiarity with EMEA regulatory authorities and compliance frameworks.
- Experience working within a global or matrixed organization.
- Exposure to regulatory inspections involving multi-country operations.
- Quality or Regulatory certifications (e.g., RAC, ASQ).
- Strong analytical, risk management, and problem-solving skills.
- Excellent written and verbal communication skills.
- Additional European languages preferred.
- Quality or Regulatory certifications preferred but not required.
About BEPC
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
Apply Now!
Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples demonstrating MDSAP experience, Notified Body interactions (BSI/TÜV preferred), QSR-to-QMSR knowledge, and proactive Quality Culture/program-building leadership. We look forward to connecting with you!
\nCompany DescriptionAbout BEPC
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
Company Description
About BEPC\n\nBEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
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