MacKline Pereira
Senior Risk Manager @Occlutech
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WORK HISTORY
Senior Risk Manager @Occlutech
DE
Coordinating with cross-functional teams from R&D, Manufacturing, Marketing, Clinical, Supply Chain, and Quality Assurance• Creation and review of risk management documentation, engineering requirements specifications, design verification protocols, post-market surveillance documentation, risk assessment for complaints, risk assessment for non-conformities, CAPAs, MRBs, and rationales
EDUCATION
St. Aloysius (Deemed to be University)
Under Graduate, Biology , Karnataka Board
Manipal Institute of Technology
Bachelor’s Degree, Biomedical Engineering
St. Aloysius Institute of Education, Mangalore
High School, Karnataka Board
SKILLS
ABOUT MACKLINE PEREIRA
A results-driven Biomedical Engineer with a background in Regulatory Affairs, Quality Assurance & Product Development looking to leverage my broad skill set, strategic thinking, and collaborative attitude towards improving healthcare outcomes and bringing safe and effective medical technologies to market.Experienced with medical devices such as - Patient Monitoring System, EEG/PSG Amplifiers, Neonatal Phototherapy System, Therapeutic Laser Systems, Medical RF System, RF Microneedle System, ECG and data management software, Dental Products, Prosthetic Locks and Heart Implants.Experienced in performing activities such as - Documentation required for EU-MDR transition of active medical devices, complying with risk management as per ISO 14971, supporting the product development teams all through the design controls, supporting technical documentation for regulatory submissions, analysis and remediation of documents such as QMS documents, DHFs, documentation of Usability/ Human Factors Engineering as per IEC 62366-1, drafting Clinical Evaluation Reports as per EU-MDD and EU-MDR requirements, and drafting US FDA Traditional 510(k) submissions.Focused on a career in the healthcare sector and a driven passion to learn and thrive in the Medical Devices domain, I am actively looking forward to connecting with Organizations for new full-time job opportunities.
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