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Biocompatibility Medical Device information

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How much do biocompatibility medical device jobs pay per hour?

As of Jun 10, 2026, the average hourly pay for biocompatibility medical device in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Biocompatibility Medical Device Specialist, and why are they important?

To thrive as a Biocompatibility Medical Device Specialist, you need a strong background in biomedical engineering, materials science, or a related field, along with knowledge of regulatory standards like ISO 10993. Familiarity with laboratory testing, risk assessment tools, and regulatory submission systems is typically required, and certifications such as RAC (Regulatory Affairs Certification) can be advantageous. Critical thinking, attention to detail, and effective cross-functional communication are standout soft skills for this role. These skills and qualities are crucial to ensure device safety, regulatory compliance, and successful product development in the medical device industry.

What are the typical challenges faced by professionals working in biocompatibility for medical devices?

Professionals in biocompatibility for medical devices often face the challenge of navigating complex regulatory requirements while ensuring accurate testing and documentation. They must stay updated with evolving standards such as ISO 10993 and communicate effectively with cross-functional teams, including R&D, regulatory affairs, and manufacturing. Balancing thorough risk assessments with project timelines can be demanding, and close attention to detail is crucial when interpreting test results and preparing submission reports. Collaboration and adaptability are key to overcoming these challenges and ensuring patient safety.

What is a biocompatibility specialist for medical devices?

A biocompatibility specialist for medical devices is a professional responsible for evaluating whether a medical device is safe and compatible with human tissue. Their main role is to assess the potential for adverse biological reactions when a device comes into contact with the body. They design and oversee tests to ensure devices meet regulatory standards, such as ISO 10993, and help prepare documentation for regulatory submissions. This role is crucial in ensuring that products are safe for patients and comply with global health regulations.

What is the difference between Biocompatibility Medical Device vs Biocompatibility Specialist?

AspectBiocompatibility Medical DeviceBiocompatibility Specialist
CredentialsRegulatory knowledge, testing certificationsBiocompatibility testing certifications, scientific background
Work EnvironmentManufacturing, testing labs, regulatory agenciesResearch labs, testing facilities, regulatory bodies
Industry UsageDesign, manufacture, and approval of medical devicesConducting biocompatibility assessments and research

The main difference is that a Biocompatibility Medical Device refers to the actual device designed for medical use, while a Biocompatibility Specialist focuses on testing and assessing the device’s biocompatibility to ensure safety and compliance.

Infographic showing various Biocompatibility Medical Device job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Senior Regulatory Affairs Specialist -FDA Medical

Wacker Chemie AG

Ann Arbor, MI • On-site

Full-time

Posted 6 days ago

Job description

Ann Arbor, MI, USA, 48108
Posting Start Date: 6/1/26
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
To strengthen our team in Ann Arbor,
we are looking for you as a(n) Senior Regulatory Affairs Specialist -FDA Medical.
Senior Regulatory Affairs Specialist-FDA Medical
  • Responsible for managing Wacker Chemical Corporation's corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
  • Responsible for refining Wacker's corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications.
  • Evaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
  • Prepars and submits forms and applications for Wacker FDA Drug and Device Master Files. Prepare portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation and preparing and submitting Medical Device Master File (MAF) packages and updates.
  • Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing.
  • Awareness of drug facility registration requirements would be useful. For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products.
  • Recognition of the differences between US and Canadian regulations. Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent
  • Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
  • Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG). Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process.

Requirements:
  • Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.
  • 7+ years of experience preferred.
  • Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
  • Strong leadership, interpersonal and problem-solving skills.
  • Experience working in cross-functional teams.
  • Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
  • Experience in polymer chemistry is preferred.

Apply