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1+ months

Global Biocompatibility Specialist, MDR

Kelly Services
Morrisville, NC 27560
**Kelly Services is actively recruiting for a Global Biocompatibility Specialist, MDR in the Greater Raleigh, NC area for a Direct Hire within the Biotechnology Industry.**


**POSITION SUMMARY:**


Oversee all MDR gap assessments of biocompatibility data for Clients products. Review historical testing data in a variety of databases to determine applicability per the new MDR initiative. Produce a technical document summarizing the applicable testing and/or identifying remediation plans when gaps are detected.


**PRINCIPAL RESPONSIBILITIES:**


Create a technical document which outlines the applicability of testing on file and/or outlines gaps to address. Work with other functions to determine appropriate sample(s) to produce an efficient and effective remediation plan compliant to MDR 2017/745.

Perform gap assessments of products by evaluating device BOMs to determine the applicability of test data to materials of construction. Review of historical data may also include gap assessments for any historical testing that was conducted on an inactive part of ISO 10993.

Maintain and execute the biocompatibility program/policy for Client to endure all products and processes comply with the regulatory standards.

Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Clients products.

Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.

Perform miscellaneous projects and duties as assigned.

Adhere to and ensure the compliance of Client Code of Conduct, all company policies, rules, procedures, and housekeeping standards.


**EDUCATION / EXPERIENCE REQUIREMENTS** :


B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science.

Minimum of 2 years of experience performing or reviewing medical device biocompatibility test reports.


**SPECIALLIZED SKILLS/ OTHER REQUIREMENTS**


Strong communication and technical writing skills

Biocompatibility Evaluation and Testing Standards Knowledge (ISO 10993, ISO 18562, MDR 2017/745, FDA Guidance 1811, etc.)

MS Office Experience (word, excel, access, PowerPoint)

Strong problem-solving skills

Ability to communicate and operate effectively with cross-functional teams.

Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-09 Expires: 2021-10-09

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Global Biocompatibility Specialist, MDR

Kelly Services
Morrisville, NC 27560

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