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Manager Eu Mdr Jobs in Indiana (NOW HIRING)

Eightelevengroup

Software Quality Engineer

Warsaw, IN · On-site

$76 - $88/hr

Review test case execution results and manage software defects * Facilitate software risk ... 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA) * Collaborate closely with R&D and cross ...

New

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Review test case execution results and manage software defects * Facilitate software risk ... 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA) * Collaborate closely with R&D and cross ...

Thermo Fisher Scientific

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing. * Vision requirements for this position:

Zimmer, Inc.

Senior Development Engineer II

Warsaw, IN · On-site

What You Can Expect You have a design owner and/or project manager role with responsibility for new ... FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized ...

Thermo Fisher Scientific

Quality Engineer

Indianapolis, IN

$68K - $88K/yr

ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing. * Vision requirements for this position:

avalign

Sr. Design Quality Engineer

Fort Wayne, IN · On-site

... Quality Management System (QMS). The Design Quality Engineer will be responsible to ensure that ... and the EU Medical Device Regulations (MDR). * Supports, reviews, and approves the following ...

BSI Group

... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...

BSI Prof Serv EHS West

... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...

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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 popular job titles related to Manager Eu Mdr jobs in Indiana?

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

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

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

Manager Eu Mdr jobs near you

Software Quality Engineer

Eightelevengroup

Warsaw, IN • On-site

$76 - $88/hr

Other

Posted yesterday

New

Job description

Software Quality Engineer

Warsaw, IN

Hybrid role (3 days in office)

$55 - $64 per hour

ABOUT THE ROLE

Join a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle—from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.

WHAT YOU'LL DO
  • Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products
  • Provide leadership, guidance, and expertise on software development processes, procedures, and practices
  • Serve as a subject matter expert in requirements gathering, test strategy definition, and design controls
  • Facilitate documentation and tracking of verification activities, including code review findings
  • Review test case execution results and manage software defects
  • Facilitate software risk assessment sessions and own the development of risk documentation
  • Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation
  • Provide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topics
  • Conduct training on medical device software development processes and quality systems; develop associated work instructions
  • Provide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirements
WHAT YOU BRING
  • Bachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)
  • Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineering
  • Experience in the medical device industry
  • Proficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)
  • Strong interpersonal, organizational, and verbal/written communication skills
  • Ability to work collaboratively in a team environment and demonstrate leadership
  • Ability to perform duties in accordance with company policies, procedures, and civil rights requirements
  • ASQ Certification as a Software Quality Engineer or equivalent (preferred)
  • Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)
  • Ability to facilitate software risk assessments and develop risk documentation
WHAT'S IN IT FOR YOU
  • Opportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences company
  • Exposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvement
  • Meaningful mentorship scope and cross-collaborative team and business partners
  • Hybrid work environment (3 days in office)
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