REGULATORY AFFAIRS SPECIALIST / QUALITY ASSURANCE ENGINEER

Job Description

REGULATORY AFFAIRS SPECIALIST / QUALITY ASSURANCE ENGINEER (Medical Devices)

• Manage all regulatory affairs activities in support of medical device product development including, P re-Clinical, Risk Analysis, Clinical Evaluation, Biocompatibility, Post market surveillance Post Market Vigilance issues.

• Preparing Implementing Quality Systems Quality Control documentation.

• Design Verification Validation activities.

• GMP ISO Requirements activities.

• Risk Managementactivities.

• Represent or lead the RA function on assigned cross-functional project teams.

• Develop and execute regulatory plans for the Critical Care product portfolio, including new products and maintenance of licenses/authorizations for existing marketing authorizations.

• Monitor applicable regulatory requirements; assure compliance with external standards . (ISO 13485, CE certification, FDA certification MDR requirements).

• US-FDA Establishment registration 510K preparation submissions.

• Inspection Test Plan Good Manufacturing Practices.

• Facing conducting Internal Audits.

• Develop and document sound regulatory decisions and justifications.

• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.

• Review promotional material or SOPs for compliance with local and global regulations.

• Support product owner in assembly of process/product regulatory submission and assist in follow up questions.

• Perform gap analysis and propose solutions.

• Support in GMP or pre-licensing inspections conducted by authorities.

• Conducting Internal Audits Preparation of documentation for the same and facing External Audits

• Identify the Nonconformities within the Internal system at each stage of product development and close the same.

• Should have degree in Biomedical/Biotechnology or degree in a related field.

• Should have experience working in the regulatory team of a medical device industry.

• Experience in medical device listing / establishment registration / ISO Documentation / medical device reporting.

• Understanding of international regulatory requirements for medical devices. (ISO 13485/MDD 93/42 EEC/ MDR)

• Proven track record in writing dossiers for regulatory device submissions.

• Knowledge of creating and making a Design History File (DHF)

• Fluency proficiency of English Language is must.

• Proficient in working with Computer including MS Word/Excel/Power Point etc.

• Ability to successfully manage projects to deadlines.

• Bachelors / Masters in Biomedical, Biotechnology Engineering or related field.

• Candidates with a background from Biomedical Engineering, Medical Professional, Healthcare professional, would be preferred.

• 2-5 Yearsexperience in FDA regulated Medical and Healthcare Industries.

• Thane (Ambernath) Mumbai (Suburban).

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