Devahasan Krishnakumar
Mississauga,Canada
Summary
Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Bringing [Number] years of [Industry] experience and seeking a growth-oriented position. Knowledgeable about [Industry] practices and regulations. Attentive and exacting with demonstrated success in handling domestic and international regulatory needs for diverse products. Systematic and practical with sound judgment, an analytical mindset and good problem-solving skills. Adept at managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. Well-spoken and friendly with top-notch abilities in information verification, report preparation and records management. Committed job seeker with a history of meeting company needs with consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
6
6
years of professional experience
Work History
Regulatory Affairs Specialist
Optum (Previously Change Healthcare Canada Company)
Remote, ON
07.2022 - Current
- Provided input on regulatory-related queries and formulated business plans for regulatory strategy for upcoming software releases
- Conducted research on submission requirements for Canadian market
- Prepared, coordinated submitted regulatory applications & amendments to Health Canada for Class II devices
- Assisted the director of RA with planning and execution of EU MDR requirements for the enterprise imaging products
- Drafted and coordinated documentation changes to ensure that technical files and design dossiers were up to date prior to each release & submission
- Monitored the latest changes to standards, regulations and guidance documents by tracking them on a weekly basis
- Timely updates were provided to the management & cross functional team to maintain awareness & compliance
- Fostered a good working relationship with product management, R&D, UX and Radiologists through weekly meetings, training sessions and bug fix discussions.
- Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
- Performed gap analysis to identify areas where additional information was needed to meet local registration requirements.
- Monitored changes in international regulations and standards relevant to products under development or already registered.
- Managed upkeep of regulatory electronic and hard copy filing systems and archives.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
Regulatory Affairs Intern
Procter & Gamble
Toronto, ON
09.2021 - 07.2022
- Conducted regulatory reviews for cosmetic, fabric and homecare products, ensuring compliance with Canadian guidelines
- Ensured that product submissions/documents/data is maintained and kept up to date
- Collaborated with brand, project managers, legal and QA by providing guidance & regulatory requirements on adverse events, new product launches and business continuity plans (BCP)
- Critically analyzed & improved two processes which helped reduce formula review time and maintain data accuracy
- Tracked cosmetic hotlist and NDSL/restricted ingredients to estimate annual import volumes & comply with trigger limits
- Assisted regulatory manager with the completion of Health Canada surveys under the Chemicals Management Plan (CMP).
- Collaborated with internal departments such as Quality Assurance, Research and Development, Legal, Clinical Affairs, Regulatory Compliance and Marketing Communications teams on various projects related to regulatory affairs processes.
- Reviewed labeling materials to ensure compliance with applicable laws and regulations.
- Prepared regulatory documentation and presentations and highlighted findings to support project leads.
Project Manager
Trylon Engineering Services
Brampton, ON
01.2018 - 09.2021
- Prepared and reviewed project plans, project checklists, project schedules and budget
- Monitored and responded to emails for product inquiries/quality complaints
- Delegated major issues to internal teams for resolution
- Clearly communicated to the management and clients about the state of project, risks, issues, milestones and proposed solutions
- Worked and cultivated relationships with key stakeholders by keeping them informed and involved during the complete project lifecycle
- Worked closely with QA manager for risk mitigation – Implemented quarantine plans for isolating quality issues
- Spearheaded vendor training for improvements in product quality which resulted in increased customer satisfaction & retention.
- Submitted project deliverables to clients, consistently adhering to quality standards.
- Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
- Reviewed project risks and devised proactive strategies to avoid potential roadblocks.
- Collaborated closely with senior management on long-term strategic planning initiatives related to projects in development or execution stages.
- Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
- Maintained records of all documents related to each project including specifications, change orders, invoices.
- Communicated effectively with stakeholders to ensure project goals are met on time and within budget.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
Education
Master of Science - Medical Device Regulatory Affairs
Northeastern University
Bachelor of Engineering - Biomedical Engineering
Toronto Metropolitan University (Formerly Ryerson)
Toronto, ONSkills
- Project Management Tools: JIRA, Confluence, Smartsheet, Customer complaint handling
- Computer Programs: DOT Compliance, Master Control, Veeva Vault, 3DExperience (Enovia)
- Regulatory Knowledge: SOR/98-282, UK MDR, EU MDR, 21 CFR 820
- Standards Knowledge: ISO 13485, ISO 14971, ISO 15223-1, IEC 60601
- Impact Assessment
- Labeling Requirements
- Technical Documentation
- Project Management
- Active Listening
- Data Verification
- International Regulations
- Product Information
- Audits
Additional Information
Additional information and recommendations available at www.linkedin.com/in/devahasankrishnakumar
Volunteer Experience
- Northeastern University Regulatory Affairs (NURA), Advisory Committee, Toronto, Canada, 01/2022, 05/2022
- GlobalMedic, P&G Gives Back Volunteer, Toronto, Canada, 2021, Present
- Engineers Without Borders Ryerson University, Director of Marketing & VP External, Toronto, Canada, 2016, 2017
- TEDxRyersonU, Productions team & Technology Manager, Toronto, Canada, 2012, 2015
Languages
English
Native/ Bilingual
Malayalam
Full Professional
Tamil
Full Professional
Timeline
Regulatory Affairs Specialist
Optum (Previously Change Healthcare Canada Company)
07.2022 - Current
Regulatory Affairs Intern
Procter & Gamble
09.2021 - 07.2022
Project Manager
Trylon Engineering Services
01.2018 - 09.2021
Master of Science - Medical Device Regulatory Affairs
Northeastern University
Bachelor of Engineering - Biomedical Engineering
Toronto Metropolitan University (Formerly Ryerson)
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