*** ********** ****

Durham, North Carolina ****3

Cell Phone: 919-***-****

E-mail: acehlg@r.postjobfree.com

Professional Experience:

Over 25 years of diversified experience in clinical and regulatory

management, quality assurance and operations, research and new product

development in the biotech, chemical, pharmaceutical and medical device

industries.

Present and Past Positions:

o Director International Regulatory Affairs and QA - Teleflex Medical,

Research Triangle Park, North Carolina 27703 from 4/2008 to 6/6/2014

Teleflex is a global provider of medical devices used in critical care

and surgery and serves healthcare providers in more than 130 countries

with specialty devices for vascular access, general and regional

anesthesia, urology, respiratory care, cardiac care, and surgery.

Key Roles and Responsibilities:

1. This position has a key role in identifying pivotal development tracks

for Teleflex products and in identifying optimal path to marketing

authorization.

2. Develops and implements strategies for timely submission and approval

of submissions at all stages of development including pre-clinical

submissions, applications for clinical trials if required, and ongoing

maintenance, licensing applications, and post-approval submissions to

regulatory agencies, including FDA, Health Canada, EMA, local European

agencies and other regulatory agencies in South East Asia and Asia

Pac regions including Australia and India such as TGA, CDSCO, and

PMDA.

3. Develops a strategic timeline for key meetings with regulatory bodies

and advisors; prepares the team for, and leads such meetings.

4. Participates in assessment of product safety for timely safety

reporting to regulatory agencies.

5. Maintain product registrations and ensures all registration approval

renewals are completed timely.

6. Register new products in Asia Pacific Market which includes India,

Australia, Japan, South Korea, Thailand, Taiwan, Singapore,

Philippines, Malaysia and China.

7. Responsible to ensure that Teleflex operates in regulatory compliance.

8. Instrumental in identifying appropriate regulatory tools for Teleflex

and, together with Quality Assurance Director prepares Teleflex for

regulatory inspection readiness.

9. Selects, develops and evaluates Regulatory Department personnel to

ensure the efficient operation of the regulatory affairs function.

10. Ensures that required regulatory training for Teleflex members is

identified, provided within a reasonable timeframe, and is current.

11. Develops and maintains documented regulatory procedures and supports

development and maintenance of other compliance procedures (SOPs) as

required, ensuring consistent and compliant regulatory activities.

Other Duties:

This position manages management reviews, recalls, product complaints;

label reviews, DCO approvals, and design documents review for changes

that impact registrations within ASIA, Japan and Latin America.

o Director Quality and Regulatory, Cardinal Health, Inc., Viasys Healthcare

/ NeuroCare, Madison, Wisconsin

Cardinal Health is a Fortune 21 company that improves the cost-

effectiveness of healthcare. Cardinal Health employs more than 30,000

people worldwide. NeuroCare, a division of Cardinal Health, manufactures

EEG, EMG, EP medical equipments and audio products for diagnostic and

screenings.

The position is responsible for the regulatory management and filings of

Class II and Class III in USA and EU, regulatory strategy for new

products, review labeling and promotional materials and implementation of

IRB guidelines for human testing, compliance to HIPPA, RoHS, WEE, and

DEFRA Act.

o Manager Regulatory, - Bracco Diagnostics / Acist Medical Inc., Eden

Prairie, MN

Bracco Diagnostics is the US-based subsidiary of Bracco Imaging SpA,

develops and markets clinical agents for use in X-ray/Computed Tomography

(CT), Nuclear Medicine and Magnetic Resonance Imaging (MRI) in the U.S.

and Canada. Bracco's leading products represent a significant share of

the U.S. diagnostic contrast media market. Acist, a subsidiary of Bracco

Diagnostics, is a medical device company that manufactures angiographic

injector system for controlled delivery of contrast media made by Bracco

Diagnostics for use in angiography procedures.

The position provides regulatory advice on strategy and manages projects,

acts as liaison with internal and external clients and oversees/ensures

all aspects of Regulatory Affairs day to day operation. Works globally to

provide regulatory strategy for new business and maintain existing

business by ensuring registration status are current to applicable

regulatory requirements in order to meet Bracco/Acist Medical business

goals.

o Vice-president, Regulatory Affairs, Clinical Research and Quality

Assurance - NovaMed, Inc., Minneapolis, MN

This is a start-up medical device company specialized in the development

of hydrogel mammary prostheses for revision, reconstruction, and

augmentation procedures.

Direct report to President/CEO and has operating and administrative

responsibility for Clinical, Quality and Regulatory operations.

Supervisory Skills - Direct reports included Quality Assurance Department

of three people and manage CRO for US clinical studies.

o Vice-president and Company Officer - Clinical Operations and Regulatory

Affairs - RayMedica, Inc., Minneapolis, MN - This is an orthopedic

privately funded start-up medical device company specialized in the

development of spinal implants for the relief of chronic low back pain.

Direct report to President/CEO - position has operating & administrative

responsibility for clinical and quality assurance and regulatory product

submissions.

o Director, Regulatory Affairs, Clinical Research and Quality Assurance -

ViroMed Laboratories, Inc., Minneapolis, MN

A privately owned manufacturer of in vitro diagnostic products

specializing in the manufacture of monoclonal and cell cultures for

diagnostic virology worldwide.

Direct report to the President and responsible for Quality Assurance and

Regulatory Affairs. This position managed an interdisciplinary group of

12 direct reports and 11 indirect reports. This position is responsible

for product registrations and submissions, Label Reviews, GMP training,

Product Complaints, Audit, FDA and other government agency inspection

such as EPA, government audit for government contract work, and product

recalls.

Supervisory Skills - Managed 2 Scientists, 1 Quality Assurance Engineer,

16 Medical Technologists, 1 Product Complaint Service Specialist, 3

Supervisors

o Product Regulation Manager - MEDTRONIC INC., Minneapolis, MN - 3/1992 to

7/1994.

A leading manufacturer of cardiovascular and therapeutic medical devices

focused on improving health and the quality of life worldwide.

Prepared worldwide regulatory submissions for USA 510(k)'s, IDE, PMA and

PMA supplements and international submissions for replacement heart

valves, annuloplasty rings, heart wires and other related product

accessories for EU, Japan, and Australia.

o Regulatory Affairs Associate - Boston Scientific / SciMed Life Systems

Inc., Maple Grove, MN

A leading manufacturer of cardiovascular and therapeutic medical devices

focused on improving health and the quality of life worldwide.

Prepared worldwide regulatory submissions for USA 510(k)'s, and

international submissions for guidewires, guide catheters and balloons

for angioplasty procedures.

o Regulatory Affairs Scientist - LyphoMed/Fujisawa Healthcare Inc.,

Deerfield, Illinois

Fujisawa Healthcare, Inc., headquartered in Deerfield, Illinois,

develops, manufactures and markets proprietary pharmaceutical products in

the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary

of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa

Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical

manufacturer and is actively developing its international operations in

North America, Europe and Asia.

The position is responsible for reviewing HPLC test protocols and test

reports, bioequivalence reports, product labels, product inserts, warning

and precautions, and product information inserts. Review technical

documentation for ANDA, IND and NDA submission. Review USP compendiums

o Chemist -Marion Merrel Dow, Richmond Hill, Ontario, Canada 5/1980 to

2/1985.

Marion and Merrel Pharmaceuticals acquired by Dow Chemical are leading

manufacturers of over the counter drugs such as Orifers (multivitamins

for pregnant women), Seldane ( antihistamine), Gaviscon (an antacid),

Cepacol (mouthwash) and prescription drugs, drugs such as Cardizem (slows

Calcium build up), Carafate (ulcer treatment). Marion Merrel Dow also

introduced Nicorette (anti-smoking gum),

This position is responsible for the HPLC method development for

detection of drug impurities and degradation by products and creation of

technical documents (analytical chemistry) for IND, NDA and ANDA

submissions.

Education:

Bachelor of Science, Honors General Science

University of Waterloo, Waterloo, Ontario, Canada

Bachelor of Science, Honors Chemistry and Biology

University of Waterloo, Waterloo, Ontario, Canada

Master Degree towards Biochemistry

York University, Ontario, Canada

Mini MBA (Venture Management)

University of St. Thomas, St. Paul, MN, USA

Professional Association Memberships and Seminars Attended:

Professional Association Memberships:

Regulatory Affairs Professional Society

AdvaMed - Japan Regulatory Working Group

AdvaMed - China Regulatory Working Group

AdvaMed - Taiwan Regulatory Working Group

American Society for Quality Control

American Chemical Society

National Association for Female Executives (NAFE)

Elected Co-chair of Medical Alley (MN) Regulatory Committee

RAPS Committee Member Editorial Group 20000

TAG - Member Standardization of the Biocompatibility Requirements for

Medical Devices

European Task Member for Standardization of Chemical Nomenclatures

Member of Biocompatibility Task Force- FDA/HIMA

Industry Panel Member for Biomaterial - HIMA 1993-95

Member CEN/TC 257/SC1 - 1998-99

Medical Alley (Clinical Committee) 1996-98

Invited as a Speaker for the following Seminars:

Medical Device Safety Conference - Feb. 22-24, 2014 Las Vegas, Nevada

Medical Device and Labeling Conference - April 28-29, 2013 Arlington VA

Post Market Surveillance and Product Recalls Feb. 2013 Arlington VA

International Registration Seminar - October 2013 Greensboro, North

Carolina

UDI and Labeling - October 2014 Berlin, Germany

Seminars in Spine/Orthopedics and Cardiovascular

African Society for Orthopedic Surgeon, Cape Town South Africa

Orthopedic Research Society

North American Spine Society

International Intradiscal Therapeutic Society Amsterdam, Netherlands

European Spine Society (Berlin, Munich, Wiesbaden, Frankfurt, Mainz,

Stuttgart

First Mangalore Course on Surgery of the Pediatric Spine

Spine Society - Kos, Greece

AHA - Cardiovascular Diseases/Angioplasty Techniques/Stent

Regulatory, Clinical and Quality Assurance

Regulatory Hurdles in Product Submissions in Japan

China Medical Device Regulations Summit - Shanghai 2011

Quality Issues in International Harmonization

American Clinical Research Professional

RAPS - Europe

FDA Import Detentions of Biologics - An Industry Perspective

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