Compliance Officer

1 week ago

bangalore, India beBeeRegulatory Full time

Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs specialist to join our team.Job Responsibilities:Document Preparation: Plan, coordinate, and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.MDR Gap Assessments: Perform MDR gap assessments and remediation of MDD technical files.Procedure Development: Author Regulatory department procedures, templates.Facility Registrations: Maintain annual facility registrations, device listing, GSI, and GUDID as required by US FDA.Regulatory Monitoring: Carry out monitoring regulations and standards applicable to Lamidey Noury Medical's medical devices.Impact Analysis: Conduct impact analysis of amendments to standards and regulations applicable to Lamidey Noury Medical's medical devices.Export Registration: Manage the submission of export registration files by providing the information requested by distributors and/or authorities.File Renewals: Maintain registrations by managing file renewals.Quality Contracts: Follow registration certificates and quality contracts with distributors.Priority Management: Collaborate with the export sales team to monitor registrations and prioritize them.FDA Communication: Manage 510K files and communications with the FDA.Key Requirements:Strong knowledge of regulatory affairs: Experience in regulatory affairs, including document preparation, MDR gap assessments, and procedure development.Excellent communication skills: Strong written and verbal communication skills, with the ability to communicate effectively with cross-functional teams.Attention to detail: Highly organized and detail-oriented, with a strong focus on accuracy and precision.Proactive approach: A proactive approach to identifying and addressing potential issues.Benefits:Career growth opportunities: Opportunities for career growth and professional development.Collaborative work environment: A collaborative work environment that fosters innovation and creativity.Competitive compensation: Competitive compensation and benefits package.

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