Job Description

Job Title- QA Cum RA Officer

Position Overview:

The QA RA Officer is responsible for managing quality assurance and regulatory affairs activities to ensure that the company's products comply with applicable regulations and meet the highest quality standards. This role involves working closely with product development, manufacturing, and quality teams to facilitate successful product launches and maintain regulatory compliance.

Key Responsibilities:

Quality Assurance Management:

Develop, implement, and maintain quality assurance policies, procedures, and systems in accordance with regulatory requirements (e.g., FDA, ISO 13485). Conduct regular audits and inspections to ensure compliance with quality management systems and identify areas for improvement. Oversee the investigation of non-conformances, deviations, and complaints, ensuring effective corrective and preventive actions (CAPA) are taken.

Regulatory Affairs Compliance:

Prepare and submit regulatory documentation for product approvals, including 510(k), PMA, CE Marking, and other necessary filings. Stay updated on regulatory changes and industry standards to ensure ongoing compliance and advise the organization on their implications. Liaise with regulatory agencies during product submissions, inspections, and audits, acting as the primary point of contact.

Cross-Functional Collaboration:

Collaborate with R&D, manufacturing, and marketing teams to ensure that quality and regulatory requirements are integrated into product development processes. Provide guidance and training to internal teams on quality assurance and regulatory compliance best practices. Participate in cross-functional teams to support product development projects and ensure alignment with regulatory strategies.

Documentation and Record Management:

Maintain comprehensive and organized records of quality assurance activities, regulatory submissions, and audit results. Ensure that all documentation is up to date, accurate, and compliant with regulatory requirements. Prepare and review standard operating procedures (SOPs), work instructions, and other quality-related documents.

Risk Management:

Conduct risk assessments related to product development and manufacturing processes, identifying potential quality and regulatory risks. Develop and implement risk mitigation strategies to minimize compliance risks throughout the product lifecycle. Monitor and analyze quality metrics and trends to identify opportunities for continuous improvement.

Training and Development:

Conduct training sessions for employees on quality assurance processes, regulatory compliance, and industry standards. Mentor junior QA RA team members, providing guidance and support in their professional development.

Market Surveillance and Post-Market Activities:

Monitor post-market performance of products, including adverse event reporting and vigilance activities. Collaborate with marketing and sales teams to gather feedback from customers and address any quality-related issues that arise post-launch.

Qualifications and Skills:

Education:

Bachelor's degree in Life Sciences, Engineering, Pharmacy, or a related field (Master's degree or relevant certifications are a plus).

Skills:

Strong understanding of regulatory requirements and quality management systems (e.g., ISO 13485, FDA regulations). Excellent analytical, problem-solving, and decision-making skills. Strong communication skills, both written and verbal, with the ability to convey complex information clearly. Proficiency in quality management software and document management systems.

Key Competencies:

Detail-oriented with a commitment to quality and compliance. Strong project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously. Ability to work collaboratively in a team-oriented environment. High level of integrity and professionalism in handling sensitive information.

Additional Requirements:

Willingness to travel for audits, inspections, and training as necessary. Familiarity with international regulatory requirements for medical devices (e.g., CE Marking, MDSAP) is an advantage. Ability to adapt to changing regulations and industry practices.
Job Type: Full-time

Pay: ?25,000.00 - ?30,000.00 per month

Schedule:

Day shift
Application Question(s):

how many years experience in pharmaceutical and medical device ?
how many years experience in regulatory affairs ?

Education:

Diploma (Preferred)
Experience:

Quality assurance: 2 years (Preferred)
Work Location: In person

Speak with the employer

+91 7300001696