Experience

Alcohol Countermeasure Systems Corp.

• Public Safety
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jan 2011 - Present

  - Create strategic plans for international product certification for alcohol breath analyzing and interlock device. - Monitor and review jurisdictional requirements to ensure program compliance. - Manage product submissions through liaising with cross-functional teams and government agencies. - Oversee planning and provide regulatory framework for product testing: electromagnetic compatibility (EMC), flammability, environmental, durability, and safety. - Manage test plans with the use of DVP&R (Design Verification Plan and Report) and GANTT chart. - Participate in internal audits for ISO 9001 and IATF 16949 compliance. - Analyze laboratory data and review test reports, conduct risk assessments and ensure product conformity. - Explore laws and regulations for medical device certification and establishment license. - Support corporate awareness on industry standards by complying with safety standards while maintaining customer specific requirements. - Managed the Service Organizational Control (SOC) II type 1 certification project through closing identified gaps, strengthening IT / Corporate security, providing risk management strategies, and preparing for successful audit. Show less



Bill Beauty & Health Products Ltd.

• Canada
• Health, Wellness & Fitness
• 1 - 100 Employee

• Product Development Team Leader

  • May 2008 - Aug 2010

  - Directed the R&D team in product development cycle and provided quality and regulatory support. - Co-ordinated logistics from raw materials to finished products, including cost analysis, inventory assessment, and regulatory document preparations. - Created and updated label text and product inserts, and ensured compliance with industry standards. - Worked with marketing team and coordinated annual industry trade shows. - Pioneered new business opportunities and strengthened relationships with national corporations. - Created exporting documents for oversea clients, ensured proper certification by consulates and lawyers. Show less



Apollo Health and Beauty Care

• Canada
• Manufacturing
• 200 - 300 Employee

• Regulatory Affairs & Quality Assurance Co-ordinator

  • Oct 2007 - Apr 2008

  - Provided regulatory guidance for the R&D, QA/QC, Operations, Sales and Marketing departments on label claims, patents, intellectual property for compliance to new laws and government requirements. - Documented customer complaints and adverse events. - Established regulatory database for quick retrieval of information such as SOP’s and MSDS’s. - Reviewed and updated Standard Operating Procedures (SOP’s) for internal change control and GMP compliance. - Submitted Natural Health (NPN) / Drug (NDS) / Cosmetic (CNF) Applications to Health Canada. - Provided assistance to Quality Manager in audit preparation by updating filing systems and implementing GMP. Show less



NutraLab Canada Inc.

• Regulatory Affairs & Quality Assurance Co-ordinator

  • Feb 2006 - Oct 2007

  - Executed Quality System in facility in accordance to GMP and Natural Health Product Directorate’s (NHPD’s) guidelines. - Notified management of quality deviation and provided corrective and preventative action plans to ensure safety and compliance. - Successfully renewed company’s Site License (issued by Health Canada) and obtained license for a separate addition of facility. - Generated and archived Quality documents including Standard Operating Procedures (SOP’s), Master Formulas, Batch Files, Certificates of Analysis (CoA’s), etc. - Maintained current awareness on regulations by frequently updating company staff and clients with guidelines and coordinated GMP trainings on a regular basis. Show less