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Contract Manager Medical Device Jobs in Delaware

Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. * Strong knowledge of medical procedures and the expected ...

Clinical QA Specialist

Newark, DE · On-site

$85K - $133K/yr

Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. * Strong knowledge of medical procedures and the expected ...

Clinical QA Specialist

Newark, DE · On-site

$85K - $133K/yr

Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. * Strong knowledge of medical procedures and the expected ...

Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. * Strong knowledge of medical procedures and the expected ...

Strategic Sourcing Manager

Wilmington, DE · On-site

$125K - $162K/yr

Provide guidance on procurement governance, contract compliance, and supplier issue resolution ... Experience managing MRO categories within life sciences, medical device, laboratory, or other ...

Strategic Sourcing Manager

Wilmington, DE · On-site

$125K - $162K/yr

Provide guidance on procurement governance, contract compliance, and supplier issue resolution ... Experience managing MRO categories within life sciences, medical device, laboratory, or other ...

... in medical device development? At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and ...

Lead Design Assurance Engineer

Newark, DE · On-site

$119K - $186K/yr

... in medical device development? At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and ...

... Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving ... and medical device companies worldwide. Founded in , the company is headquartered in South ...

Awareness of FDA-regulated environments and medical device quality standards (preferred). Skills ... Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial Education: * High ...

Awareness of FDA-regulated environments and medical device quality standards (preferred). Skills ... Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial Education: * High ...

Manage multiple projects concurrently under supervision. * Continue to build technical expertise ... Knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971 ...

Showing results 21-40

Contract Manager Medical Device information

What does a contract manager in the medical device industry do?

A Contract Manager in the medical device industry is responsible for overseeing the drafting, negotiation, and administration of contracts related to the development, manufacturing, and distribution of medical devices. They ensure that all agreements comply with regulatory requirements, company policies, and industry standards. Their role helps safeguard the company’s interests while fostering strong relationships with suppliers, customers, and regulatory agencies. Additionally, they work closely with legal, sales, and compliance teams to mitigate risks and resolve contractual issues.

What are some common challenges a contract manager faces when working with medical device agreements?

Contract Managers in the medical device industry often navigate complex regulatory requirements while ensuring contracts align with both business objectives and compliance standards. Challenges may include negotiating terms that adhere to FDA regulations, managing intellectual property clauses, and coordinating among legal, sales, and regulatory teams. Success in this role often relies on strong attention to detail and the ability to balance multiple stakeholders’ interests. Staying updated on evolving industry standards can also be demanding but is crucial for effective contract management.

What are the key skills and qualifications needed to thrive as a contract manager in the medical device industry, and why are they important?

To excel as a Contract Manager in the Medical Device industry, you need expertise in contract law, negotiation, and regulatory compliance, often supported by a bachelor’s degree in business, law, or a related field. Familiarity with contract management software (such as Icertis or SAP Ariba), e-signature platforms, and knowledge of FDA or EU MDR regulations are typically required. Strong attention to detail, communication, and problem-solving skills help build trust and ensure effective collaboration with stakeholders. These abilities are crucial for minimizing risk, maintaining compliance, and supporting the commercial success of medical device products.

What is the difference between Contract Manager Medical Device vs Regulatory Affairs Specialist?

AspectContract Manager Medical DeviceRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's degree in business, law, or related field; certifications like Certified Commercial Contracts Manager (CCCM) are commonRequires a degree in life sciences, pharmacy, or engineering; certifications like RAC (Regulatory Affairs Certification) are common
Work EnvironmentWorks primarily in legal, sales, or procurement departments within medical device companiesWorks in regulatory compliance departments, often collaborating with R&D and quality assurance teams
Employer & Industry UsageUsed across medical device manufacturers, suppliers, and healthcare organizationsUsed mainly in medical device, pharmaceutical, and biotech industries

The Contract Manager Medical Device focuses on negotiating and managing contracts related to medical devices, ensuring legal and commercial compliance. In contrast, the Regulatory Affairs Specialist ensures products meet regulatory standards for approval and market entry. Both roles are essential in the medical device industry but serve different functions related to compliance and legal agreements.

What are popular job titles related to Contract Manager Medical Device jobs in Delaware?

For Contract Manager Medical Device jobs in Delaware, the most frequently searched job titles are:

What cities in Delaware are hiring for Contract Manager Medical Device jobs?

Cities in Delaware with the most Contract Manager Medical Device job openings:

Vice President, Quality Engineering - BSH Division

Hologic Inc.

Newark, DE

$237K - $422K/yr

Full-time

Re-posted 19 days ago


Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

176th of 489 rated machine equipment manufacturers


Job description

The Vice President of Quality for the Breast and Skeletal Health Division is a pivotal executive leadership role responsible for developing and executing quality strategies across one of the largest divisions at Hologic Inc.

This position ensures that all products meet the highest standards of safety, reliability, durability, and performance while maintaining compliance with regulatory requirements throughout the full product lifecycle-from new product development to post-market surveillance and product lifecycle management. As a member of both the Divisional Senior Leadership Team and the Global Quality Leadership Team, you will partner with divisional leadership to drive organizational goals, provide technical expertise, and influence cross-functional initiatives at the highest levels.

Knowledge

  • In-depth understanding of FDA Quality System Regulations, ISO 13485, Medical Device Directive, Medical Device Regulation, risk management, and cybersecurity management.
  • Comprehensive knowledge of technical quality assurance and control systems, including standards, methods, and procedures for product inspection, testing, and evaluation.
  • Awareness of industry trends through review of technical publications and active engagement with regulatory authorities.

Skills

  • Demonstrated ability to lead and inspire senior leaders, including Directors, and manage large global teams.
  • Strong analytical and problem-solving skills at both managerial and technical levels.
  • Excellent written and oral communication skills, with the capacity to influence and present to regulatory bodies, technical functions, customers, field teams, and executive leadership up to the CEO.
  • Expertise in change management, independent decision-making, and conflict resolution.
  • Proficiency in hosting and managing third-party audits (e.g., FDA, notified bodies) and responding to regulatory findings.

Behaviors

  • Champion innovation and continuous improvement by capturing and communicating lessons learned and driving the adoption of new tools, technologies, and methods.
  • Excel in talent management, including attracting, hiring, developing, and retaining top talent, as well as managing succession planning and employee development.
  • Lead by example through objective setting, performance management, regular feedback, and recognition.
  • Promote a culture of quality and compliance while fostering cross-functional collaboration and stakeholder engagement.

Experience

  • Minimum of 14 years' experience in technical roles within the medical device industry, with a focus on Quality and R&D.
  • At least 6 years in a personnel management role, including experience managing other people leaders.
  • Proven track record in product launch excellence, post-market quality management, and leading quality activities related to mergers and acquisitions.
  • Experience in developing, implementing, and maintaining Quality Management Systems to support regulatory and certification requirements.

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 $237,600 - $422,400 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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