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Getinge

Regulatory Affairs Specialist I

Fraser, MI · On-site

Supports with the documentation and activities related to EU MDR, PMA, and 510(k) submissions when ... Duties are performed in an office environment or remotely (work from home). May work extended hours ...

Getinge

Regulatory Affairs Specialist I

Fraser, MI · Remote

Supports with the documentation and activities related to EU MDR, PMA, and 510(k) submissions when ... Duties are performed in an office environment or remotely (work from home). May work extended hours ...

United Church Homes

IT Security Analyst

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... from Cyber threats. This role involves monitoring the IT infrastructure for security breaches ... Develop and maintain security policies, standards, and procedures for the United Church Homes, Inc ...

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AI Enablement Engineer

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... MDR) provider. We are a force multiplier for defenders, helping organizations enhance their ... H Friday. Candidates must live in or be willing to relocate to one of these three cities. Job ...

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Linthicum Heights, MD · On-site

Ability to drive results while working from office or home. * Ability to travel 20% of the year ... MDR experience * Knowledge of regulatory compliance in the following areas: PCI; GLBA; SOX; HIPAA ...

BSI Prof Serv EHS West

... MDR (Medical Device Regulation) * Initially observe how audits are conducted but then grow to ... from your home office. In a typical week after being fully trained you'll: * Conduct an audit on ...

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Associate Director, Quality Labeling Operations # 4648

Associate Director, Quality Labeling Operations # 4648

GRAIL

Durham, NC • On-site, Remote

Full-time

Posted 5 days ago

Job description

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit grail.com

The Associate Director, Quality Labeling Operations is responsible for establishing, implementing, maintaining, and continuously improving GRAIL’s product labeling program. This role partners closely with Regulatory Affairs, Operations, Marketing, Supply Chain, R&D, Clinical Laboratory, Clinical Operations, and Design/Artwork to lead the global product labeling controls for GRAIL’s regulated in vitro diagnostic (IVD) medical devices. This individual contributor role is the SME responsible for the development, implementation, and lifecycle management of compliant product labeling content, including Instructions for Use (IFU), Unique Device Identifier (UDI) labeling, and other product labeling elements required under FDA, EU IVDR/MDR, and U.K. MHRA regulations. The individual applies critical thinking and sound judgment to solve broad, complex problems and regularly communicates status, risks, and recommendations to management.
 
Primary responsibilities include providing expertise and oversight to ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485:2016, ISO 14971:2019, 21 CFR 801, 21 CFR 820, 21 CFR 809, Unique Device Identifier (UDI) requirements and related in vitro diagnostic medical device regulations.  
 
This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.
 
Responsibilities:
  • Serve as the primary process owner for product labeling operations activities within the Quality Management System (QMS).Establish, maintain, and improve product labeling processes, procedures, and infrastructure (including electronic labeling systems, proofing, and physical and electronic distribution controls).
  • Establish and maintain labeling specifications and source artwork files (printed and electronic).
  • Ensure all product label claims are substantiated through the Design History File in partnership with Regulatory, Design Quality, and Research, Design, and Operations teams.
  • Partner with Marketing and Regulatory teams to align product labeling controls with advertising/promotional labeling controls, which are managed by the Promotional Material Review Committee and led by Marketing.
  • Initiate and support Veeva change control workflows for product labeling specifications which evaluate design history file (DHF) and risk management file (RMF) impacts.
  • Maintain inspection-ready product labeling documentation and traceability between product labeling, risk files, and technical documentation.
  • Ensure only current, approved product labels are distributed in print and electronically.
  • Drive cross-functional alignment and governance for labeling, ensuring Regulatory, Legal, and Clinical Study content oversight and compliant execution.
  • Manage label verification and validation, including proof review, barcode functionality, and compliance with UDI, GUDID, and GS1 requirements.
  • Provide direction to cross-functional teams on product labeling compliance requirements.
  • Align global core product labeling with regional requirements while supporting local adaptations for major markets.
  • Represent the Product Labeling Program as Subject Matter Expert during audits and inspections.
  • Monitor global regulatory changes and lead labeling process updates to maintain compliance that is aligned with our Commercial strategy.
 
Required Qualifications:
  • BS/BA degree & 10+ years of related experience, or Masters & 8+ years of related experience, or PhD & 5+ years of related experience.
  • Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 801, 21 CFR 809, 21 CFR 820, ISO 13485:2016, ISO 14971:2019, MDR/IVDR.
  • Experience establishing and implementing medical device UDI, compliant with both FDA and EU regulations." 
  • Proven expertise remediating and improving a medical device labeling process to ensure an effective, compliant, inspection-ready program.
  • Experience using an eQMS required; Veeva Vault preferred.
  • Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
  • Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
  • Experience supporting regulatory inspections/audits and responding to findings.
  • Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
  • Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
  • Excellent written and verbal communication skills and attention to detail.
  • Ability to comprehend and interpret technical information related to GRAIL's product claims.
  • Experience preparing for, leading, and supporting FDA and EU Notified Body regulatory inspections/audits and effectively responding to findings.
Preferred Qualifications:
  • BS/BA degree & 12+ years of related experience
  • ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred.
  • Experience working within a clinical laboratory (high complexity CLIA/CAP environment, compliant with ISO 15189) preferred.
  • Next Generation Sequencing (NGS) experience preferred.
Physical Demands and Work Environment
  • Work performed in office, production, and laboratory environments; frequent cross-functional engagement.
  • Travel may be required to support audits, inspections, or collaboration with global teams and suppliers.
  • Use of PPE in production and laboratory settings may be required.
  • Standard weekday schedule with flexibility for extended hours during regulatory inspections, customer visits, or critical investigations.
 
The expected, full-time, annual base pay scale for this position is $146,000 - $194,000 .  Actual base pay will consider skills, experience, and location.

This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at rc@grailbio.com if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!