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
[pic]