US & OUS Regulatory Affairs and Quality System Specialist - Edina, Minnesota (General Resumes, CV, Curriculum Vitae) - MedJump.com

US & OUS Regulatory Affairs and Quality System Specialist

Edina, Minnesota - US

Job Target: Regulatory Affairs Specialist
Employment Status: Employed - Actively Looking
Experience Level: Mid Level
Seeking: Full-Time
Industry: General Resumes

Salary: $70,000/yr
Degree: Bachelor's Degree (BA/BS)
Security Clearance: None
Travel: Heavy
Relocate:: Yes

Resume Tags regulatory affairs quality fda iso 13485 mdd cross-functional eu canada all tags

Objective

Focused Regulatory Affairs Specialist role at a dynamic and growing organization.

Job Target

Regulatory Affairs Specialist

Professional Experience

2006 – present	Sybaritic, Inc. Regulatory Affairs and Quality System Manager	Bloomington, MN
	Regulatory Compliance • Compiled and submitted three 510 (k) applications (K082028, K082033 and K083272) for Class II laser and intense pulsed light (IPL) devices. • Along with international distributors, manage product registration submissions in individual countries. Experience with EU, Taiwan, Thailand, Russia, Singapore, Australia, Korea, Canada, Saudi Arabia and more. • Review product labeling and advertising materials for compliance with domestic and international Medical Device regulations and recommend appropriate changes to affected personnel when necessary. • Manage MDR and EU Medical Device Vigilance reporting. • Compile and maintain product Technical Files to meet EU MDD requirements. Quality Systems Compliance • Implemented complete Quality System to meet ISO 13485 and EU MDD requirements for Sybaritic Bloomington facility. Received certification from Notified Body TUV Rheinland in December, 2010. • Implemented complete Quality System to meet ISO 13485 and EU MDD requirements for Sybaritic Beijing facility. Expect to receive final certification from Notified Body TUV Rheinland in November, 2011. • Implemented and managed internal quality system audit program, evaluating compliance with ISO 13485, MDD and CMDCAS requirements • Extensive cross-functional collaboration with product development, QC, technical service, purchasing, marketing and shipping & receiving.
2004 – 2005	Schwegman, Lundberg & Woessner International Case Management Group Representative	Minneapolis, MN
	Worked with attorneys in filing of international intellectual property patent applications.

Education

2004	Minnesota Paralegal Institute Paralegal Studies – Associate or Vocational Degree (AA/AS/MCSE/etc.)	Minnetonka, MN
	ABA Paralegal Certificate
2002	Florida State University Sports Management – Bachelor's Degree (BA/BS)	Tallahassee, FL
	Business degree with emphasis in sports marketing and management.

Relocation Preferences

California, Florida, Arizona

Last updated on: 2011-11-03.