Regulatory Compliance Associates® Inc. (RCA), A Nelson Labs company, provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges. Our recent acquisition by Sotera Health, a leading global provider of mission-critical sterilization, lab testing and advisory services further broadens our global presence within the life science industries.

Job Description:

RCA is seeking a Product Development Engineer to support projects within our Medical Device practice. Applicants should remain flexible in remote working or travel as required. Ideal candidates will be willing to listen, shadow, learn, and grow into a productive independent consultant. Projects can range from all classes of medical device, for companies of all sizes, and at all stages of development. Client-focus and satisfaction is key.

Job Responsibilities:

• Participate in a wide variety of medical device development projects as a consultant on a team under the guidance of a Senior Consultants and Subject Matter Experts.
• Read and interpret consensus standards and regulatory guidance, while helping the client understand the process in tandem.

Qualifications:

• Engineering degree in one of the following disciplines: Biomedical, Mechanical, Electrical, Software, Chemical or Materials
• Bachelor of Science degree, with 4-7 years of applicable work experience
• Advanced degree with 3 – 5 years of applicable work experience preferred
• Basic Knowledge of Design Controls (21 CFR 820.30, and ISO 13485)
• Basic Knowledge of Risk Management (ISO 14971, dFMEA, uFMEA, pFMEA)
• Basic Knowledge of QSR and QMS (ISO 13485, 21 CFR 820)
• Basic understanding regulatory submissions (FDA, EU MDD or MDR)
• Understanding of software development lifecycle (ISO 62304 and Cybersecurity guidances)
• Microsoft Office Suite Expert
• Project management experience (project planning, tracking, Gantt charts etc.) preferred
• Understanding of Usability Engineering (IEC 62366) preferred
• Understanding of biocompatibility and biomaterials (ISO 10993) preferred
• Experience interfacing with Quality Assurance preferred
• Experience in support of Manufacturing Engineering preferred
• Confident, independent worker who is results-focused, flexible, and willing to ask questions

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Nelson Labs takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

VEVRAA Federal Contractor

To learn more about RCA, visit About Us | Life Science Industry Consulting Services | RCA®