Website:
meshayuconsultants.com
Job details:
Company Description
MESHAYU CONSULTANTS PRIVATE LIMITED is headquartered in Ahmedabad, India, and operates from its base at Swati Clover near Shilaj Circle in Gujarat. The company specializes in offering a range of consultancy services to meet diverse client needs. Known for its expertise and professional approach, MESHAYU CONSULTANTS supports its clients in achieving their objectives with innovative and customized solutions.
Role Description
This is a full-time on-site role for a USFDA 510k Specialist located in Gujarat, India. The USFDA 510k Specialist will be responsible for compiling, preparing, and submitting 510k regulatory documentation for obtaining clearance. The role includes performing gap assessments, maintaining compliance with regulatory requirements, liaising with regulatory bodies, and ensuring accurate and timely submissions. Additionally, the specialist will stay updated with USFDA guidelines and provide support for regulatory audits.
Qualifications
- Strong understanding of USFDA 510k submission process and regulatory compliance
- Experience with documentation, report writing, and regulatory submissions
- Knowledge of medical device regulations, standards, and quality management systems
- Proficiency in project management with excellent attention to detail, deadlines, and organizational skills
- Ability to interpret and apply technical and regulatory information effectively
- Strong analytical, problem-solving, and critical thinking skills
- Excellent verbal and written communication skills
- Relevant certifications or advanced degree in Regulatory Affairs or a related field is a plus
- Experience with international regulatory requirements is advantageous
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