FDA CAPA Lead: Audit Readiness & Regulatory Strategy
Accord Technologies Inc
Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality, Compliance, or Regulatory roles within regulated industries. Responsibilities include leading FDA audit readiness activities, conducting gap assessments, and mentoring teams on FDA expectations. The position demands strong hands-on experience with CAPA management systems and regulatory compliance, ensuring effective leadership during inspections and audits. #J-18808-Ljbffr Accord Technologies Inc
- ...FDA Audit Readiness Lead Lead FDA audit and inspection readiness activities across the business. Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes... .../interface for FDA inspections, regulatory meetings, and compliance...Regulatory
- ...highly experienced professional to lead FDA audit and inspection readiness activities. This role requires 10 years... .... The ideal candidate will own CAPA effectiveness, prepare for FDA inspections... ...expectations. Strong leadership, regulatory knowledge, and excellent...Regulatory
- ...is actively seeking a qualified professional to lead FDA audit and inspection readiness activities in Bothell, Washington. The ideal candidate... ...Compliance, with strong hands-on experience in CAPA, FDA inspections, and regulatory compliance programs. This role entails mentoring...Regulatory
$110k - $137k
...Management, Data Integrity, and Audit Readiness to support patient safety... ...internal procedures. Leads formal risk assessments... ...controls, mitigation strategies, and preventive actions.... ...Monitors and interprets FDA, EMA, ICH, and other regulatory expectations related to Quality...RegulatoryRemote jobFull timeCasual workLocal area$104.63k - $161.9k
A leading medical device company in Bothell is seeking a Manager of Regulatory Compliance to oversee internal/external audits and compliance programs. This role requires a Bachelor's degree, a minimum of 3 years in a regulated environment, and strong leadership skills....Regulatory- Philips is seeking a Global Supplier Quality Audit Coordinator to manage external supplier audits and ensure robust compliance... ...audit schedules, documenting findings, and supporting readiness for regulatory audits. The ideal candidate has over 7 years in the medical...RegulatoryWork at office3 days per week
$87.93k - $108.16k
...trust. As the Payroll Lead, you are not just an... ...Compliance & Tax Strategy: Lead all payroll tax... ...tools, leading system audits and configuration updates... ...with audit requests and regulatory reporting... ...Public company or IPO-readiness experience Target...RegulatoryFull timePart timeWork experience placementWork at officeLocal areaRemote workWork from homeFlexible hours3 days per week1 day per week$106.4k - $203.6k
...Overview The Solution Play & Demand Generation Strategy Lead is responsible for driving top-of-funnel strategy, account-based engagement... ...campaigns that drive new pipeline opportunities. Produce executive-ready visuals, funnel metrics, and pipeline waterfall views to...Ongoing contractLocal area$172k - $250k
...Information Security Audit & Compliance to join the... ...Audit & Compliance to lead and scale a global... ...combines deep audit and regulatory expertise with strong... ...Audit & Compliance Strategy Define and lead the... ...internal testing, and readiness assessments. Track...RegulatoryInternshipSeasonal workWork at officeLocal areaFlexible hours3 days per week- A leading aerospace quality management firm located in Bellevue is seeking a Supplier Quality Engineer. This role involves conducting supplier audits, leading MRB activities, and providing technical guidance to suppliers. Candidates should possess 8+ years of experience...
$64k - $108k
Tata Consultancy Services is seeking an Azure Infra Ops Lead to build and scale foundational security and governance capabilities... ...vital for governance automation, compliance enforcement, and regulatory readiness. The ideal candidate will have strong Azure expertise,...Regulatory$157.9k - $315.9k
Premera in Mountlake Terrace is seeking a Compliance Executive to lead enterprise compliance strategies and ensure adherence to regulatory obligations. The ideal candidate will have significant management experience and a strong background in regulated industries. Your...Regulatory- A leading health technology company in Bothell, WA seeks a Senior Regulatory Affairs Specialist to secure timely product clearances for ultrasound devices. Responsibilities include preparing regulatory submission documents for agencies and providing strategic guidance....RegulatoryFull timeWork at office
$168.32k - $252.48k
...law. Manager, Internal Audit We are seeking a Manager... ...ensure efficient, and audit-ready control environment. This... ...financial, operational, and regulatory Develop and implement strategies to mitigate risks and... ...from potential liabilities. Lead risk assessments and collaborate...RegulatoryFull timeTemporary workLocal areaRelocation package- ...a Sr. Specialist in Electronic Quality Management Systems. You will administer the MasterControl eQMS, ensuring compliance with regulatory standards and managing quality system processes. The ideal candidate has over 10 years of experience in biopharmaceutical settings...Regulatory
$102.8k - $159.4k
...our team as an Environmental Regulatory Compliance Leader today! We have... ...-motivated individual to lead local and regional compliance... .../Hazardous waste Compliance auditing Oil Storage/SPCC plans SARA... ...local and regional marketing strategies Support safety efforts to promote...RegulatoryFull timeLocal area- A leading technology firm is seeking an Energy & Climate Policy Engagement Lead to guide regulatory and policy analysis in power markets. You will engage with stakeholders, analyze energy policies, and develop strategies for both U.S. and European markets. Ideal candidates...Regulatory
- ...EXPLORATION TECHNOLOGIES CORP (SpaceX) seeks a Satellite Policy Manager in Redmond, WA to drive regulatory and policy strategy for Starlink Mobile. This pivotal role involves leading efforts to ensure compliance with telecommunications regulations and advocating for policy...Regulatory
- A leading aerospace company in Redmond is seeking a Satellite Policy Manager to drive regulatory strategies for its Direct to Cell satellite network. The ideal candidate will have expertise in telecommunications policy, strong advocacy skills, and a Bachelor’s degree. Key...Regulatory
$83.25k - $163.93k
...Healthcare in Bothell, Washington is seeking a skilled professional to lead complex contracting activities within health plan provider... ...2 - $163,931 annually, with a focus on relational negotiation and compliance with regulatory standards. #J-18808-Ljbffr Molina HealthcareRegulatoryRemote job$125k - $180k
A leading aerospace manufacturer is seeking a Sr. Satellite Policy Manager to oversee regulatory strategy for Starlink in the APAC region. The ideal candidate will have a Bachelor's degree and extensive experience in telecommunications policy and regulatory affairs. This...Regulatory- ...at their Bothell facility. This role is pivotal in managing deviations, conducting investigations, and ensuring compliance with regulatory standards. The ideal candidate will possess strong communication skills and a proactive approach to quality assurance. You will work...Regulatory
- A leading clinical-stage biopharmaceutical company in Redmond, WA, seeks a Principal Scientist... ...leadership, ensuring compliance with regulatory standards, and collaborating across multiple teams to influence biomarker strategy. This full-time position is ideal for candidates...RegulatoryFull time
- ...required cash handling, and ensuring the floor and stock room are ready for the business day. Responsible for opening back door of... ...any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required...RegulatoryWork experience placementSeasonal workLocal areaShift work
- ...manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits. Responsibilities: Performs general and/or more complex manufacturing formulation batch production record reviews and...Regulatory
$157.9k - $315.9k
What you’ll do Set strategy and lead enterprise compliance. Lead the design... ...with applicable legal and regulatory requirements, including services... ...and oversee responses to audits and examinations. Track investigations... ...deliver clear, executive‑ready reporting to leadership and...RegulatoryWork experience placement- ...and scale AI with confidence. Trusted by leading AI labs, startups, and global... ...Climate Policy Engagement Lead to lead regulatory and policy analysis and engagement related... ...industry working groups. Policy Analysis & Strategy Monitor, analyze, and synthesize regulatory...RegulatoryPermanent employmentTemporary workCasual workWork at officeRemote workFlexible hours
- ...more connected career At CableCom, LLC, as a Lead Safety, you’ll serve as a senior safety leader, driving safety strategy, mentoring team members, and coordinating... ...and near-misses Coordinate internal audits and regulatory inspection readinessDevelop and deliver custom...RegulatoryWork at officeRemote work
$104.7k - $133.3k
...waste, and environmental control programs. Assist in environmental permit applications and corrective strategies. Manage projects and communicate with regulatory agencies. Support proposal writing and client relationship development to secure repeat business. Classify...RegulatoryWork at officeWorldwide$133k - $183k
...Manager of Supplier Performance leads the supplier-facing supply... ...function responsible for supplier readiness, performance, and execution... ...with Procurement on supplier strategy and sourcing decisions -... ...production readiness, and applicable regulatory requirements (ITAR/EAR)...RegulatoryPermanent employment
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