Laura Lind Email and Phone Number
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Laura Lind personal email
Helping you meet your regulatory needs: US FDA, EU MDR, EU MDD and global submissions; detailed assessment of change; Regulation (EU) 2017/745 (MDR) gap assessments, technical documentation, timely submissions.
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Regulatory Affairs FellowFang Consulting, LtdSaint Paul, Mn, Us
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Regulatory Affairs FellowFang Consulting, Ltd Oct 2017 - PresentRoseville, Mn, UsDirector of Regulatory Affairs for Fang Consulting, Ltd. Delivering thorough gap analyses of Regulation (EU) 2017/745 (MDR) by establishing the current level of compliance of Class lla, llb, and lll technical files for an industry leading medical device company. Team recommends procedural and documentation updates to resolve identified gaps. Identifies the best transition strategy for the medical device manufacturer based on product ranges, markets, and certification cycle. Constructs analysis methods and best practices with team of consultants to meet project staffing and deadline needs.Our team performs detailed assessment of changes, product development team support, develops and/or maintains European Technical Files for Class I, IIa, IIb and III devices, including combination devices. We have device and pharma personnel on staff. -
Principal Ra ConsultantFang Consulting, Ltd Jan 2016 - PresentRoseville, Mn, UsHelping you meet your regulatory needs: US, EU and global submissions and quality systems review.* PMA 30-day Notice of Change* EU Technical File creation and maintenance* Experience with STED format* 510(k) submissions and Letters to File* Regulatory Assessment of changes for all Classes* Quality Systems review* CER review for compliance to MEDDEV 2.7/1 Rev. 4 (2016)* Experience with electro-medical and software-driven devices
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Sr. Regulatory Affairs SpecialistNonin Medical, Inc. Oct 2014 - Jan 2016Plymouth, Minnesota, UsProduct specialist supporting patient monitoring systems. Broad regional experiences including technical files for CE-marking, 510(k) clearance, Brazil, LATAM, Asia-PAC and EMEA registrations. -
Device ConsultingConsultant Jul 2014 - Oct 2014Focus on EU Technical File updates to maintain compliance.Initiatives included team building and team cross-training on regulatory issues.
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Sr. Regulatory Affairs SpecialistCovidien Jul 2012 - Jun 2014Fridley, Minnesota, UsProduct specialist focusing in US and EU submissions. Cross-functional team experience including product launch support, process improvement and business unit re-branding initiative.Review of labeling, marketing and promotional materials to ensure compliance to regulations. -
Regulatory Affairs SpecialistBoston Scientific Dec 2006 - Jul 2012Marlborough, Ma, UsExperience in International, including Asia and Latin America;US Import/Export regulations;PMA/510k support and submissions;Distribution Control methods/quality systems
Laura Lind Skills
Laura Lind Education Details
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Iowa State UniversityNuclear Engineering
Frequently Asked Questions about Laura Lind
What company does Laura Lind work for?
Laura Lind works for Fang Consulting, Ltd
What is Laura Lind's role at the current company?
Laura Lind's current role is Regulatory Affairs Fellow.
What is Laura Lind's email address?
Laura Lind's email address is la****@****sci.com
What schools did Laura Lind attend?
Laura Lind attended Iowa State University.
What are some of Laura Lind's interests?
Laura Lind has interest in Arts And Crafts, Camping, Knitting, Renovating My Home.
What skills is Laura Lind known for?
Laura Lind has skills like Iso 13485, Regulatory Affairs, Fda, Medical Devices, Design Control, Ce Marking, Capa, V&v, Gmp, Regulation 2017/745, Regulatory Requirements, Technical Files.
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