Meg Carr, RAC

**** **. ******* **** ***** Rosa, CA 95409

(H) 707-***-**** (C) 707-***-**** abnhi0@r.postjobfree.com

SUMMARY

Energetic, inventive management professional with more than 15 years of diverse and strategic domestic and international

regulatory, quality, project management and marketing experience in the medical device industry. Extensive background in

submissions (IDE, 510(k), PMA, Technical File and Design Dossier) and all device classes, including Class III implantable

cardiovascular, endovascular, and combination devices. Regulatory and Quality support for all phases of international and

domestic product concept-to-market life cycle, strategic planning, team-based program management, and product launch.

PROFESSIONAL EXPERIENCE

Provide strategic, personalized, hands-on regulatory affairs, quality assurance and design

Independent

control consulting services to medical device companies:

Consultant

• Create and support 510(k) and PMA submissions; conduct submission review for compliance

Santa Rosa, CA

with current regulations and guidance documents; support response to regulatory agency

2006 to present

inquiries. (PMA approved; 510(k) created and provided to client within 20 working days,

pending FDA decision)

• Project management of concept to market launch while fulfilling Regulatory, Quality and Design

Control requirements (concept to market launch completed for one client in less than 8

months).

• Establish, evaluate and update Quality System procedures to comply with current international

and domestic regulations, leading to successful California State inspection and licensing.

• Support international device studies, including submission to Ethics Committees and

Competent Authorities.

• Create new product regulatory, quality, and clinical strategies, leading to on-time product

launch.

• Update and administer Quality System training to new employees.

Conduct Quality System gap assessments and support corrections for 3rd party audit readiness.

•

• Conduct system audits and review/support closure of audit findings.

• Create product labeling and conduct promotional material review.

• Support all company functions as requested and as required to meet project deadlines.

Medtronic, Inc. Director of Compliance (2005-2006)

•

Santa Rosa, CA Managed and closed three worldwide field actions, interfacing with international offices and

1995 to 2006 US and international Regulatory Agencies.

• Interfaced with Medtronic Japan contacts to prepare division for PAL requirements.

• Represented facility during various FDA and international audits with successful outcome (no

483, low-severity findings).

• Led and managed cross-division, cross functional audit team in preparation for Corporate audit,

resulting in successful outcome and reduction of findings.

• Managed complaint handling and MDR/Vigilance system department.

• Managed internal audit employees and audit program to meet US and international quality

and regulatory requirements.

• Managed GLP Quality Control group.

• Updated company-wide Quality System training material and performed influential division-

wide training.

• Provided regular updates to Senior Management regarding new processes and programs, as

well as department goal achievement.

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(continued) Regulatory Affairs Director (2003-2005)

Medtronic, Inc. Sr. Regulatory Affairs Manager (2001- 2003)

Santa Rosa, CA Regulatory Affairs Manager (2000-2001)

1995 to 2006 Regulatory Affairs Coordinator (1998 – 2000)

Senior Regulatory Affairs Specialist (1996 –1998)

Regulatory Affairs Associate (1995 – 1996)

• Directed several multi-disciplinary project teams with subsequent successful product

submissions (PMA, IDE, Technical File, Design Dossier) to FDA and Notified Body.

• Completed facility move in parallel with FDA PMA product approval for $150 million division

(165 days PMA submission to approval).

• Represented company in FDA and international regulatory agency meetings to discuss new

product innovation, product updates, and compliance requirements, and successfully negotiated

regulatory approval paths.

• Managed new device therapy information and acted as liaison with Corporate Regulatory Affairs

to address risk/benefit questions from various regulatory agencies, including FDA, UK

MHRA, and AFSSAPS (France): 522 order (Post Market Surveillance), advisory notices,

and clinical data review. Created, disseminated and tracked various physician communications

to address these questions as required.

• Represented business unit on AAMI/ISO endovascular prosthesis ad hoc committee.

• Initiated and completed company CE Marking: Investigated Notified Bodies for hire and

presented recommendation to Senior Management; supported Notified Body quality system

audits; managed and compiled several Design Dossiers, Technical Files and Notifications of

Change with subsequent approval.

• Managed international product registrations for more than 30 countries worldwide.

• Initiated company Risk Analysis program utilizing Failure Modes, Effects, and Criticality

Analysis (FMECA); represented Regulatory department on Risk Analysis teams.

• Performed labeling and promotional material review; assessed product changes for impact on

PMA, IDE, 510(k), Design Dossier, and Technical File; supported design control system;

supported process validation and engineering change order system; participated in material

review board for assessment of non-conforming manufacturing material.

• Managed Regulatory Affairs department employees.

Stryker Regulatory Affairs Specialist, International and Domestic Marketing Associate

• Authored innovative 510(k) for Class II device change in material (clearance in 90 days).

Endoscopy

• Managed international regulatory affairs including ISO 9001 and CE Marking certification.

San Jose, CA

• Directed response to nonconformances during UK Department of Health audit.

1993 to 1995

• Developed Regulatory Affairs department procedures.

• Coordinated new international and domestic product release: marketing literature, sales

training, and inventory management.

• Created international product release packages for worldwide company divisions; supported

international division marketing requirements.

EDUCATION

Dual degrees: B.S.C., Marketing; B.A., Spanish

Santa Clara University,

University of Madrid

Instituto de San Juan, Alicante, Spain

AFS foreign exchange student

Regulatory Affairs Professionals Society

Regulatory Affairs Certification (RAC)

Lead Assessor

Quality Systems Course

LANGUAGES/ PROFESSIONAL MEMBERSHIPS/ VOLUNTEER WORK

Spanish/ Regulatory Affairs Professional Society (RAPS), Phi Sigma Iota (National Foreign Language Honor Society),

Toastmasters International/ Santa Rosa Mother’s Club “In-A-Pinch” volunteer/ Dance Docent and classroom volunteer.

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