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Contract Manager Medical Device Jobs in Delaware

Fusion Life Sciences

System Engineers

Newark, DE · On-site

Newark, DE Long Term Contract Job Overview: We are seeking highly skilled and experienced System ... The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong ...

Hologic Inc.

CAPA Facilitator Associate

Newark, DE · On-site

$78K - $122K/yr

Ability to manage diverse tasks with minimal day-to-day supervision. * Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.

Hologic

CAPA Facilitator Associate

Newark, DE · On-site

$78K - $122K/yr

Ability to manage diverse tasks with minimal day-to-day supervision. * Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.

Hologic

CAPA Facilitator, Engineer

Newark, DE · On-site

$97K - $152K/yr

... medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems. * Experience with Agile or an equivalent Product Lifecycle Management system is ...

Hologic Inc.

CAPA Facilitator, Engineer

Newark, DE · On-site

$97K - $152K/yr

... medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems. * Experience with Agile or an equivalent Product Lifecycle Management system is ...

Straumann

Territory Manager - Delaware

Wilmington, DE · On-site

As a Territory Manager, you will embody our core values of collaboration, agility, ownership, and ... Experience in the medical device industry. Prior sales experience with physicians as the principal ...

Intuitive

Clinical Sales Manager

Wilmington, DE · On-site

Previous record of managing and directing a sales team in the medical device industry * Excellent communication and interpersonal skills * Computer literate * Training Requirements: Attend ISI field ...

Intuitive

Clinical Sales Manager

Wilmington, DE · On-site +1

Previous record of managing and directing a sales team in the medical device industry * Excellent communication and interpersonal skills * Computer literate * Training Requirements: Attend ISI field ...

Straumann

Territory Manager - Delaware

Wilmington, DE · On-site

As a Territory Manager, you will embody our core values of collaboration, agility, ownership, and ... Preferred Qualifications: • Experience in the medical device industry. • Prior sales experience ...

Datavant

Client Partner, Pharma

Dover, DE · On-site

$160K - $180K/yr

Deep understanding of life sciences companies (biopharma, medical device, CROs). * Experience ... line managers to "C" level executives. * Highly consultative, hands on and collaborative.

Hologic Inc.

Senior Embedded Software Engineer

Newark, DE · On-site

$121K - $158K/yr

Partner with Product Management and domain experts to define product improvements and new features ... Experience in the medical device industry. * Experience with medical imaging or general image ...

ZOLL Medical

Patient Service Representative

Dover, DE · On-site

$14 - $17.75/hr

Spanish Speaking Preferred The Cardiac Management Solutions division of ZOLL Medical Corporation ... Manage device and garment inventory * Disclose family relationship with any potential referral ...

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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:

Contract Manager Medical Device jobs near you

System Engineers

Fusion Life Sciences

Newark, DE • On-site

Contractor

Re-posted 13 days ago

Job description

Title: System Engineer

Location: Newark, DE

Long Term Contract
 

Job Overview:

We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle.

Key Responsibilities:

  • Design Controls: Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.
  • Traceability: Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
  • User Needs to Design Validation: Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive Design History Files (DHF) and validation documentation.
  • Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
  • Cross-Functional Collaboration: Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle.
  • Documentation and Reporting: Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
  • Continuous Improvement: Identify areas for process improvements in design control and traceability methods, and implement changes that enhance the efficiency and effectiveness of product development.

Required Qualifications:

  • Experience: 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries.
  • Design Controls: Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
  • Traceability: Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
  • Regulatory Knowledge: In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices.
  • Collaboration: Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
  • Strong verbal and written communication in English

Preferred Qualifications:

  • Risk Management: Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971).
  • V&V Experience: Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements.
  • Software and Tools: Experience with requirements management tools, traceability software, and common V&V tools.

Personal Attributes:

  • Strong analytical and problem-solving skills
  • Ability to manage and prioritize multiple tasks in a fast-paced environment
  • Detail-oriented with a commitment to accuracy
  • Proactive and able to work independently or as part of a team
     
    Sincerely,
    Subash Kondala
    Medical/Pharma Recruiter
    www.fusionlifesolutions.com 
    Subash@fusionlifesolutions.com
    Direct Number: (312)447-9550
    linkedin.com/in/subash-kondala-a5a39424a
    For all jobs with Fusion https://tinyurl.com/56f356a3
    6110 McFarland Station Dr Suite 502 Alpharetta GA 30004