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Director Ivd Product Development Jobs in Indiana

BSI Group

EMEA/UK- Homebased BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are ...

BSI Prof Serv EHS West

EMEA/UK- Homebased BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are ...

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Director Ivd Product Development information

What does a director IVD product development do?

A Director of IVD (In Vitro Diagnostics) Product Development leads teams responsible for creating and improving diagnostic devices and assays used in laboratory testing of biological samples. They oversee the entire product development process, from concept through design, testing, regulatory approval, and market launch. Their role involves strategic planning, cross-functional collaboration, ensuring compliance with regulatory standards, and managing timelines and budgets. Directors in this field play a critical role in bringing innovative diagnostic products to market that improve patient care.

What are the key skills and qualifications needed to thrive as a director IVD product development?

To thrive as a Director of IVD Product Development, you need deep expertise in in vitro diagnostics, product lifecycle management, and regulatory requirements, usually supported by an advanced degree in a scientific or engineering field. Familiarity with product development tools, quality management systems (such as ISO 13485), and regulatory submission platforms (like FDA or CE Mark processes) is essential. Strong leadership, strategic thinking, and cross-functional communication skills help drive innovation and align multidisciplinary teams. These skills ensure the successful development and launch of compliant, high-quality diagnostic products that meet market and regulatory demands.

What are some common challenges faced by a director IVD product development and how can they be addressed?

A Director of IVD Product Development often encounters challenges such as navigating complex regulatory requirements, aligning cross-functional teams, and managing tight project timelines. Successfully addressing these challenges requires staying up-to-date with evolving regulations (e.g., FDA, CE marking), fostering clear communication among R&D, regulatory, and marketing teams, and implementing robust project management practices. Building strong relationships with stakeholders and encouraging a culture of transparency can help to anticipate risks early and keep product development on track.

What is the difference between Director Ivd Product Development vs Product Manager Ivd?

AspectDirector Ivd Product DevelopmentProduct Manager Ivd
ResponsibilitiesOversees entire product development teams, strategic planning, and long-term product visionManages specific product features, coordinates cross-functional teams, and executes product plans
Required CredentialsTypically requires advanced degrees and extensive industry experienceOften requires a bachelor's or master's degree with relevant experience
Work EnvironmentLeadership role within R&D or product development departments in medical device companiesCollaborates across engineering, marketing, and regulatory teams in similar settings

The main difference is that the Director Ivd Product Development focuses on strategic leadership and overseeing the entire product development process, while the Product Manager Ivd handles day-to-day product planning and execution. Both roles require industry-specific knowledge and collaboration across teams, but the director has a broader scope and higher level of responsibility.

What are popular job titles related to Director Ivd Product Development jobs in Indiana?

For Director Ivd Product Development jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Director Ivd Product Development jobs in Indiana look for?

The top searched job categories for Director Ivd Product Development jobs in Indiana are:

What cities in Indiana are hiring for Director Ivd Product Development jobs?

Cities in Indiana with the most Director Ivd Product Development job openings:

Director Ivd Product Development jobs near you
Infographic showing various Director Ivd Product Development job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution.

Medical Device Expert- IVD (In Vitro Diagnostic)

BSI Group

Remote

Full-time

Posted 13 days ago

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job Title-Technical Specialist- IVD (In Vitro Diagnostic)

Location: EMEA/UK- Homebased

BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking people with knowledge of the design and manufacture of IVD cancer and molecular biology.

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety - this may be a great fit for you! This is a home-based position with some travel. If interested in this position, please submit your CV in English.

Essential Responsibilities:

  • Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
  • Deliver technical reviews, scheme management in support of the CE marking schemes
  • Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
  • Provide "Technical Sales/Networking" support to the commercial team

The ideal candidate will possess the following characteristics:

  • Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
  • At least (4) years' post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD cancer and molecular biology.
  • Knowledge of medical device regulations.
  • Awareness of certification business processes, the application of quality management standards, and audits

Salary Range: 63,400 - 74,500

This is a remote position that can be based in the UK or within the EMEA region. As compensation varies by country and local market conditions, salary details will be discussed with EMEA candidates prior to the interview stage

Do you believe the world deservesexcellence?

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we're truly impartial, and home to the ultimate mark of trust, the Kitemark.

Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate.Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, andengage with our global organization all while having fun doing great work.BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability orimpairment throughout out our recruiting process,please inform your Talent Acquisition Partner.

#LI-REMOTE

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About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

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