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Contract Manager Medical Device Jobs in Washington

Hp

Federal Contract Manager

Washington, DC · On-site

$113K - $164K/yr

The contracts manager will independently handle a variety of legal, contractual and compliance ... mental disability, medical condition, pregnancy, genetic predisposition or carrier status ...

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

... Medical Device company. The perfect candidate will perform the following activities: Key ... Complete the bulk download of documents and records from a Quality Management System. Required ...

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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 Washington?

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

What job categories do people searching Contract Manager Medical Device jobs in Washington look for?

The top searched job categories for Contract Manager Medical Device jobs in Washington are:

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

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

Contract Manager Medical Device jobs near you
Infographic showing various Contract Manager Medical Device job openings in Washington as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Client Manager - Medical Device QMS Auditor

The British Standards Institution (BSI)

Reston, VA • On-site

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Posted 18 days ago

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!
Job Title: Medical Device QMS Auditor
Location: Colorado
BSI (British Standards Institution) is the global business standards company that equips businesses with the solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.
This is a travel-based position requiring extensive travel to medical device manufacturing sites, including approximately 13-15 overnight travel days per month.
Purpose of role: to conduct various types of audits and work closely with clients to help them improve their performance by assessing their systems and processes against BSI standards.
Essential Responsibilities
  • Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
  • Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
  • Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications
  • Technical degree (Associate's, Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
  • Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit only experience is insufficient.
  • Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
  • Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR, are a plus.

Core Competencies
  • Strong verbal and written communication skills, and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Self-motivated, flexible, and excellent time management/planning skills.
  • Willingness to travel extensively.
  • Enthusiastic, committed team player.
  • Business development and public speaking skills are considered advantageous.

Preferred Qualifications
  • Experience with process validation, equipment qualification, and manufacturing process development.
  • Experience in design and development activities, including design controls and design transfer.
  • Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
  • Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
  • Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
  • Experience leading hands-on teams in manufacturing, testing, or validation.
  • Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
  • Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
  • Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
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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