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Click here or scroll down to respond to this candidateCandidate's Name
(C) PHONE NUMBER AVAILABLE EMAIL AVAILABLE Roanoke, VA Street Address
SUMMARYA dedicated, detail-oriented, hands-on Sr. Manager Regulatory Compliance. Ive had an exceptional career spearheading regulatory compliance activities for complex technical product lines. Im a tenacious problem solver and adept at assessing and improving processes and optimizing performance. Im an accomplished leader, talented at fostering profitable relationships with outside agencies with a track record of building alliances across internal organizations to deliver high quality competitive products in a timely and cost-effective manner. SKILLSRegulatory Agency account managementContract development and managementProduct compliance/safety issues and creativesolutionsBrand management w/regards to customerreliability and or field failures.Relationship development (internal and external)MS OfficeTeam buildingProblem resolutionSupervision/employee developmentBusiness operations - Communication andexecution corporate initiatives.Root-cause analysis of product failures usingCAPA'sContinuous Process Improvement utilizing KPI'sand A3's.Team managementCommunicationsAdministrative supportProject organizationConsumer/Industrial *& Medical Product testingSafety/EMC/Environmental CertificationsFDA submittals (familiar with PMA submittals)UL-WERCS / RoHS/REACh Data ManagementCompany acquisitions Compliance readinessEXPERIENCESenior Manager Global Regulatory Compliance, Thermo Fisher Scientific, July 2016-June 2020 Hillsboro, ORBy closely working with Operations, Marketing, Service and Legal Dept's, I had the following responsibilities:Determine, develop and manage the infrastructure and resources necessary to execute TFS product safety and compliance programs and projects.Diligently keep up with technological advances and how they are safely incorporated into our products by thorough standards evaluation and testing.Ensure proposed and developing product designs are compliant with all relevant international laws, regulations and requirements applicable to all product type categories, which includes all Environmental regulations such as RoHS, REACh, Conflict Minerals, Prop 65, etcSupport purchasing in the development of supportive software used to collect component data for REACh/RoHS.Support Field Labeling efforts with NRTL's to ensure successful product Labeling processes at customer sites.Collaborate with the appropriate International safety, testing, and certification organizations as needed to develop working relationships that result in expeditious certifications.Develop, track and communicate project performance indicators to executive level staff.Assess impact of developing standards with regards to the threats and opportunities in product development projects and communicate these to Business Unit Leaders by preparing detailed and comprehensive reports.Manage direct reports (5 Regulatory Compliance Engineers across 4 different countries) performance and training. Promote corporate culture, establish incentives and metrics, by setting and managing expectations, conducting performance evaluations and ongoing feedback on employees' performance.Lead weekly team meetings to discuss existing Mfg, construction or customer issues that impact safety or legal compliance of products.Develop, foster and promote a cooperative environment of team work among all direct reports, through open door policy, effective listening, establishing realistic expectations and effective accountability and promoting team building activities that establish and build interpersonal relationships.Established ambitious goals for employees to promote achievement and surpass business targets.Eliminated process discrepancies, implementing continuous improvements utilizing KPI's and A3's.Educate and execute executive strategies that support the corporate goals and initiatives.Identify training initiatives to improve employee performance and bottom-line business results.Established Risk-Based product development/modification processes for Material Science D.Leveraged market/compliance knowledge and leadership ability to help drive profit increases.Addressed internal and customer-related issues each day and affected strategic resolutions. Senior Manager - Regulatory Compliance, Blount International Inc., February 2009-October 2015 Portland, ORReporting directly to the VP Corporate Legal Counsel, I was tasked to lead, install and develop a first class product compliance department, encompassing all 'FLAG' (Forestry, Lawn and Garden) and Concrete Cutting business units of the corporation.Working with R&D, marketing and manufacturing departments;I develop product safety, EMC and environmental testing, based on global requirements (US, Can, EU, Korea, China, Japan and Russia) which also include RoHS/REACh/WEEE processes and procedures for the design and manufacturing of:o Consumer battery powered lawn & garden toolso Industrial concrete chainsaws, wood splitters and Safety apparel (PPE's).Manage incident investigations that involve alleged customer injuries due to possible product failures.Define HTS coding and requirements for int'l shipping hazardous goods, work with CPSC to identify product recalls (if they were to ever occur).Identify possible engineering design modifications when required/necessary.Established in-house testing procedures, instrumentation and regulatory test requirements for all relevant products, utilizing industry standards from ANSI, UL, IEC, CSA, NFPA, ISO, EGMF, OPEI, IATA, DOT and SAE, incorporating testing methodologies and acquiring applicable certifications. Senior Manager - Engineering Test Lab/Compliance Manager, LOUD Technologies Inc., February 2004- September 2009Woodinville, WAI was recruited to establish a modernized product regulatory testing and certification department and processes, managing a professional 6-member technical team to support Engineering and Compliance EMC & Safety testing in accordance to international standards.Administered a $500K annual operating budget.Established programs and policies to standardize performance and improve efficiency and productivity.Optimized product safety processes by implementing BEST practices for continuous process improvement.Lead the corporate compliance procedures pertaining to OSHA Regulations, as well as RoHS, REACh and WEEE directives as they apply to professional audio equipment.Initiated an Agency Competition' culture by cultivating relationships with various 3rd party test agencies to boost competition in order to reduce cost and improve agency performance.Support my team by establishing performance goals and initiatives for personal growth. Technical Lead Environmental Regulatory Compliance, ADIC (Advanced Digital Information Corporation), March 1999-October 2004Redmond, WALead and supervise the product safety, EMC and Environmental testing team.Source outside vendors and established productive relationshipsNegotiate cost effective contracts.Continually monitor processes and programs and identify areas for improvement.Conducted factory inspections for 3rd part agencies in accordance with OSHA, UL, TUV, CSA, ETL and ISO requirements.Develop team initiatives and establish performance goals. EDUCATION AND TRAINING College (Non-Degree +25 years experience) Engineering Physics Clark College, Vancouver, WA ACCOMPLISHMENTS At Loud, I built and equipped a 3m EMC chamber that had +/-3dB performance compared to the certification lab. I mention it because it took a year dedication to get it put together and functional..And it was beautiful. Immediately profitable, saving Loud over $150K in pretesting the first year. Additional Professional Development Course Work:Certified Fire & Arson Investigator - NFPACertificate in Hazard Based Safety Engineering - HPCertificate in Thermal Imaging Analysis InframetricsCertificate in FMEA Blount Int'lEffective Negotiation Hewlett Packard and Blount Int'lProject Management Cadence Corp, and Hewlett PackardLeadership, Team Building Thermo Fisher UniversityExecutive Strategic Planning Thermo Fisher University DiversityTraining and Implementation Blount Int'l, Thermo Fisher and Hewlett PackardLeadership, Cultivating Respect Blount Int'l and Hewlett PackardAGILE, SAP, SharePoint, and ORACLE Database Management Labview and HP-Vue Automatic Test Equipment (ATE)ACTIVITIES AND HONORSI chaired the IEEE, SW Washington/Oregon Chapter Product Safety Engineering Society from 2013 to 2016. International Product Standards I have worked with: I have an intimate or working knowledge of the following industry international standards:UL/CSA/IEC 60745-1, UL/CSA/IEC 60335-1, UL 62368, WERCS/21 CFR 1910.1200, UL/CSA/IEC 60950, EN/UL 60101-1, UL2054, UL1642, EN55014, EN55022, CISPR24 and 14, ISO13845/21 CFR 820, EN62133, 2006/42/EC, 2004/108/EC, 2001/95/EC, 2002/44/EC, 2000/14/EC, 2005/88/EC, 2002/95/EC, 2002/96/EC, OSHA, as well as a vast number of ISO (9000, etc...) ANSI, OPEI, and DIN standards.For the EU specifically, I have a deep working knowledge of WEEE registration, RoHS/REACh requirements (including SCIP database) Conflict Minerals and Prop 65 (California only).Additionally, through a number of consulting jobs, I have a working knowledge of CPSC product recall process where I was asked to assist my clients with effectively, and successfully, working their products through this process. |
