James Mitchell
james.mitchell.94@gmail.com | (617) 555-0847 | Boston, Massachusetts | www.linkedin.com/in/jamesmitchell94

PROFESSIONAL SUMMARY

Detail-oriented QA and RA Junior Specialist with expertise in regulatory compliance and quality assurance within the biotechnology and medical device sectors. Proven ability to prepare and manage technical documentation for regulatory submissions while ensuring adherence to international standards. Strong communicator with excellent English proficiency and a commitment to maintaining the highest quality standards in highly regulated environments.

WORK EXPERIENCE

QA and RA Junior Specialist
Precision BioMed Solutions, Boston, Massachusetts
June 2023 - Present

- Support preparation and submission of regulatory documentation for medical device products, ensuring compliance with FDA, EU MDR, and ISO 13485 standards
- Collaborate with cross-functional teams to review technical files, risk assessments, and clinical evaluation reports for regulatory submissions
- Maintain and update quality management system documentation, including SOPs, work instructions, and quality records
- Assist in internal audits and supplier audits, identifying non-conformances and tracking corrective and preventive actions (CAPA)
- Coordinate responses to regulatory authority inquiries and support post-market surveillance activities

Quality Assurance Intern
Nexus Biotech Corporation, Cambridge, Massachusetts
January 2023 - May 2023

- Assisted in document control activities, including review, approval, and archiving of quality documentation
- Participated in deviation investigations and contributed to root cause analysis reports
- Supported validation activities for manufacturing processes and equipment qualification protocols
- Conducted training sessions for laboratory staff on GMP and quality procedures

EDUCATION

Bachelor of Science in Biotechnology
Massachusetts Institute of Life Sciences, Worcester, Massachusetts
Graduated: May 2022

Relevant Coursework: Regulatory Affairs, Quality Systems Management, Bioprocess Engineering, Molecular Biology, Pharmaceutical Biotechnology

SKILLS

Regulatory Affairs: FDA regulations, EU MDR, ISO 13485, regulatory submissions, technical documentation
Quality Assurance: GMP, quality management systems, CAPA, internal audits, document control
Biotechnology: Bioprocessing, medical devices, pharmaceutical development
Technical Documentation: Technical writing, SOP development, regulatory dossiers, clinical evaluation reports
Languages: English (fluent), technical writing proficiency
Software: MS Office Suite, quality management software, document management systems

CERTIFICATIONS

- RAC (Regulatory Affairs Certification) - In Progress
- ISO 13485:2016 Internal Auditor Training - Completed 2023

PROFESSIONAL DEVELOPMENT

- Member, Regulatory Affairs Professionals Society (RAPS), 2023-Present
- Attended workshop on EU Medical Device Regulation (MDR) Implementation, 2024