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Manager Eu Mdr Jobs in Delaware (NOW HIRING)

Hologic Inc.

Lead Design Assurance Engineer

Newark, DE

$119K - $186K/yr

... management, and global regulatory compliance are maintained from concept to product launch. In this ... 42/EEC, EU MDR, and MDSAP. * Familiarity with reliability modeling and testing for electro ...

Hologic

Lead Design Assurance Engineer

Newark, DE · On-site

$119K - $186K/yr

... management, and global regulatory compliance are maintained from concept to product launch. In this ... 42/EEC, EU MDR, and MDSAP. * Familiarity with reliability modeling and testing for electro ...

Hologic

Sr Manager, Regulatory Operations

Newark, DE · On-site

Job Summary: The Senior Manager, Regulatory Operations provides strategic and operational ... Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, EU MDD/MDR ...

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Manager Eu Mdr information

What does a Manager EU MDR do?

A Manager EU MDR oversees an organization’s compliance with the European Union Medical Device Regulation (EU MDR). They are responsible for developing, implementing, and maintaining processes to ensure that medical devices meet all regulatory requirements for sale in the European market. This role includes coordinating regulatory submissions, managing documentation, and liaising with notified bodies and regulatory authorities. The manager also stays updated on regulatory changes and ensures that the company’s products and processes are continuously compliant. They often provide guidance and training to internal teams on EU MDR requirements.

What are the key skills and qualifications needed to thrive as a Manager EU MDR?

To thrive as a Manager EU MDR, you need in-depth knowledge of European Medical Device Regulation (MDR), regulatory affairs experience, and a relevant degree in science, engineering, or a related field. Expertise in using regulatory submission systems, quality management tools (like ISO 13485), and familiarity with notified body processes are typically required. Exceptional organizational, leadership, and communication skills help manage cross-functional teams and complex documentation. These skills ensure compliance, product approval, and successful navigation of the evolving EU medical device regulatory landscape.

What are some common challenges faced by a Manager EU MDR, and how can they be effectively addressed?

A Manager overseeing EU MDR (Medical Device Regulation) compliance often encounters challenges such as keeping up with evolving regulatory requirements, coordinating cross-functional teams, and managing documentation for audits. Staying informed through continuous professional development and industry updates is key to staying compliant. Effective communication and collaboration with regulatory, quality, and R&D teams can help streamline processes and ensure timely submissions. Leveraging regulatory management software and establishing clear SOPs can also improve efficiency and reduce errors.

What is the difference between Manager Eu Mdr vs Regulatory Affairs Specialist?

AspectManager Eu MdrRegulatory Affairs Specialist
CredentialsTypically requires advanced degrees and experience in medical devices and EU regulationsUsually holds a degree in life sciences or regulatory affairs, with certifications in regulatory processes
Work EnvironmentLeads teams, manages compliance projects, and interacts with multiple departmentsFocuses on preparing documentation, ensuring regulatory submissions, and supporting compliance tasks
Industry UsageCommonly used in medical device companies within the EUFound across medical device, pharmaceutical, and biotech industries
Search & Comparison IntentOften compared for roles with managerial responsibilities in EU MDR complianceCompared for specialized regulatory roles supporting EU MDR adherence

The Manager Eu Mdr oversees compliance teams and strategic implementation of EU MDR regulations, while the Regulatory Affairs Specialist handles documentation and submission tasks. Both roles require regulatory knowledge, but the manager has broader leadership responsibilities.

What are the most commonly searched types of Eu Mdr jobs in Delaware?

The most popular types of Eu Mdr jobs in Delaware are:

What are popular job titles related to Manager Eu Mdr jobs in Delaware?

For Manager Eu Mdr jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Manager Eu Mdr jobs in Delaware look for?

The top searched job categories for Manager Eu Mdr jobs in Delaware are:

Manager Eu Mdr jobs near you

Corporate Quality and Clinical Auditor

Hologic

Newark, DE • On-site

Full-time

Re-posted 24 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

180th of 495 rated machine equipment manufacturers

Job description


As a Corporate Quality and Clinical Auditor, you will support company-wide clinical quality and compliance programs through execution of risk-based audits, audit system oversight, regulatory intelligence, and inspection readiness. This role evaluates clinical quality systems, supports global regulatory compliance and provides expert leadership across internal and external audit activities. This role develops and maintains audit electronic audit systems, analyzes data for reporting, and supports risk-based and special audits, including those related to new acquisitions and transfers.
The auditor evaluates and monitors corrective actions, supports FDA inspections and external audits, and facilitates inspection-readiness training.
Essential Duties and Responsibilities
  • Manage key components of the compliance audit program under the Community of Practice for Quality Audits to ensure process and product conformance per company and regulatory requirements.
  • Evaluate, maintain, and analyze compliance audit metrics to ensure internal and external audit results are properly tracked across Hologic locations.
  • Support the Director of Internal Audit in the annual Compliance Audit report for the Executive team.
  • Develop and manage special audit tasks and support the risk-based approach for clinical audits.
  • Evaluate and monitor corrective actions from clinical audits; coordinate joint audits, special compliance gap assessments, and FDA inspection readiness training.
  • Support FDA and external audit activities as assigned.
  • Identify compliance issues, evaluate risks associated with clinical activities, and drive internal manufacturing compliance improvements to reduce compliance risk.
  • Support clinical audit activities for recently acquired companies or products, maintain and update the electronic audit module, assess external regulatory trends, and provide strategic updates on clinical compliance performance.
Supervisory Responsibilities
  • ☒ None
Qualifications Education Basic Qualifications
  • B.S. in Engineering, Science, or related field. (Strongly recommended focus in Electrical or Electronic engineering, Chemist, Microbiology or Science)
  • Active Certification as IRCA, RABQSA, ASQ CMDA (preferred), ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead Auditor Qualification by a recognized organization
  • Minimum of 8 years of experience in one or more of the following areas: Quality Engineering, R&D, Compliance, Quality Operations with focus in installation, servicing, refurbishing activities, chemical compliance, clinical studies, current Good Clinical Practices
  • Minimum of 5 years' experience as a Clinical or Lead Auditor in a regulated industry
Experience & Skills Regulatory and Technical Knowledge Required
Documented courses with assessments are preferred
  • ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 20916:2019 - In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects
  • ISO 14971:2019 - Medical devices - Application of risk management to medical devices
  • ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO/IEC 27001 - Information security for clinical data systems
  • Regulation (EU) 2017/745 - Medical devices (MDR)
  • Regulation (EU) 2017/746 - In vitro diagnostic medical devices (IVDR)
  • UK Medical Devices Regulations 2002 (as amended)
  • US FDA 21 CFR Parts 11, 50, 54, 56, 812
  • US FDA 21 CFR Parts 800-898 - Medical Device Regulations (incl. 21 CFR 820 - QMSR)
  • US FDA Bioresearch Monitoring Program (BIMO)
  • Canada: SOR/98-282 - Medical Devices Regulations
  • Australia: Therapeutic Goods (Medical Devices) Regulations 2002
  • Japan: Pharmaceuticals and Medical Devices Act (PMD Act)
  • Brazil: Law No. 6.360/1976 and associated ANVISA medical device RDCs
  • European Union: Regulation (EU) 2017/745 - Medical Devices (MDR); Regulation (EU) 2017/746 - In Vitro Diagnostic Medical Devices (IVDR)Good Clinical Practices and Good Laboratory Practices
  • Statistical techniques and sampling plans
  • Process, equipment and design validation, test method validation
  • Software validation requirements (product and non-product)
  • Expert skills using SharePoint, Teams, PowerPoint and Excel
Highly desired
  • Additional working knowledge of European Standards and Regulations
  • Experience in other global regulatory requirements e.g. Korea, China, Swiss, UK etc.
  • Working knowledge of Artificial Intelligence regulations and standards
  • Strong project management and failure investigation/root cause analysis skills
  • Current ASQ certifications, e.g. CMDA, CQA and CQE
  • Excellent written and verbal communication skills
  • Strong interpersonal and cross-functional leadership skills
  • Multilingual e.g. English and Spanish, German, French, or Chinese

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $138,000-$230,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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