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Locum Medical Device Design Jobs in Raleigh, NC (NOW HIRING)

NIRSense Inc

Principal Electrical Engineer

Morrisville, NC · On-site

$130K - $159K/yr

Deep hands-on expertise with design and integration of electrical components of miniaturized medical device systems such as PCBs, PCB components, batteries, and light-emitting and detecting systems.

MMS

Study Design Statistician (US)

Raleigh, NC · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Assisting customers with their study design with a particular focus on simulation with KerusCloud ...

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Locum Medical Device Design information

What is a locum medical device design professional?

Locum medical device design professionals are experts who temporarily fill roles in the design and development of medical devices, often to cover staff shortages or support specific projects. They bring specialized knowledge in engineering, regulatory compliance, and product development, and may be involved in tasks such as prototyping, testing, and documentation. These professionals help companies maintain productivity and meet deadlines without the commitment of a permanent hire. The locum arrangement offers flexibility for both the employer and the professional, and is common in industries requiring highly specialized skills.

What are the key skills and qualifications needed to thrive as a locum medical device design professional?

To thrive as a Locum Medical Device Designer, you need a solid background in biomedical engineering, product design, and regulatory standards, often supported by a relevant degree and prior experience in device development. Familiarity with CAD software, rapid prototyping tools, and knowledge of FDA or CE compliance processes are typically required. Strong problem-solving, adaptability, and effective collaboration skills help individuals excel in varied project environments and short-term assignments. These competencies ensure the delivery of innovative, compliant, and user-centered medical devices within tight timelines.

What are some common challenges faced by locum medical device design professionals when integrating into new teams and projects?

Locum medical device design professionals often face the challenge of quickly adapting to new team dynamics and project workflows. Since projects may be at various stages of development, locums must rapidly familiarize themselves with existing designs, documentation, and regulatory requirements. Effective communication and collaboration with both engineering and clinical teams are crucial to ensure seamless integration and contribute to project goals. Flexibility and a proactive approach to learning company-specific processes can help locums succeed in these dynamic environments.

What is the difference between Locum Medical Device Design vs Contract Medical Device Engineer?

AspectLocum Medical Device DesignContract Medical Device Engineer
CredentialsRelevant engineering degrees, certifications in medical device designSame as locum, often with specialized certifications
Work EnvironmentTemporary assignments in various companies or projectsProject-based, often in corporate or manufacturing settings
Employer & Industry UsageUsed by staffing agencies, hospitals, and medical device firmsEngaged by companies for specific projects or product development

Both roles involve designing medical devices, requiring similar credentials and working in related environments. The key difference is that a locum medical device designer works temporarily across different organizations, while a contract medical device engineer is typically hired for specific projects within a single company.

What are popular job titles related to Locum Medical Device Design jobs in Raleigh, NC?

For Locum Medical Device Design jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Locum Medical Device Design jobs in Raleigh, NC look for?

The top searched job categories for Locum Medical Device Design jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Locum Medical Device Design jobs?

Cities near Raleigh, NC with the most Locum Medical Device Design job openings:

Locum Medical Device Design jobs near you

Senior Regulatory Affairs Specialist

Bioventus LLC

Durham, NC • On-site

$90 - $120/hr

Other

Re-posted 6 days ago

Job description

Position

Senior Regulatory Affairs Specialist – Durham, NC – Bioventus LLC.

Responsibilities
  • Author and submit regulatory applications (510(k), PMA supplements, and technical documentation) to obtain product clearance and approvals for new products and maintain existing registrations globally.
  • Author and maintain Technical Files compliant with MDD 93/42/EEC and EU MDR 2017/745.
  • Communicate with regulatory agencies regarding product submissions, changes (manufacturing, design, new development), and to represent regulatory affairs during internal and external audits.
  • Review protocols, reports, and marketing literature for scientific validity and regulatory compliance, providing scientific judgment to guide cross‑functional teams.
  • Perform regulatory assessments for design, manufacturing, and labeling changes to ensure compliance with applicable regulations and standards where the product is registered.
  • Research requirements, set priorities, and maintain project schedules; provide guidance and oversight to team members on regulatory compliance matters.
Qualifications
  • Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, or a related field, plus a minimum of 3 years of experience in a regulatory affairs or related role within the medical and/or diagnostic device industry.
  • 3+ years of experience with regulatory assessment of engineering/design change execution; guiding cross‑functional teams; and preparing submission documents.
  • Regulatory registrations in at least three of the following agencies or regions: FDA, EMEA, Canada, LATAM, Japan, Australia.
  • Experience with product changes and submissions compliant with Medical Device Regulation (MDR) and EU Medical Device Directive (MDD).
  • Project management experience and proficiency in preparing and reviewing documentation regarding product changes.
Work Arrangement
  • Hybrid model: 3 days in office and 2 days remote within commuting distance.
  • National travel required approximately 25% of the time.
EEO Statement

Bioventus is committed to fostering an inclusive and diverse community. Qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion, or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.

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