D I A N E C. T I E R N A N

***.***. **** [cell] adb6fd@r.postjobfree.com

www.linkedin.com/in/dianectiernan

P R O F E S S I O N A L P R O F I L E

Senior Regulatory Affairs Professional effective collaborator with strategic partnerships involving both medical device and biotech companies utilizing medical device experience for developing pre-market strategies for 510(k)s, IDEs, PMAs and combination products for worldwide regulatory authorities leading and managing successful submissions and post-market activities with medical device development experience for global markets developing pre-market strategies for 510(k), IDE and PMA and combination products worldwide both leading successful submissions and managing post-launch activities. Adept at building credibility and working effectively with senior management, engineers, quality managers, manufacturers, FDA, EU and other global regulators to identify and manage the most optimal regulatory path to market for the organization(s).

Seeking an opportunity to lead a regulatory team on behalf of a medical device company to develop cost effective strategies to bring innovative medical technology to markets worldwide based on my extensive experience working with large and small organizations and corporate partnerships.

H I G H L I G H T S

Developed Quality Plan with contract manufacturer for inhaled route of drug delivery device resulting in 2 successful internal audits and one external audit by partner Notified Body. Required collaboration and consensus of the contract manufacturer, strategic partner and Biotech Company to complete these audits with a minimal number or no findings.

Developed strategy and presentation to EU Competent Authority in collaboration with strategic partner to defend Class I status of dry powder inhaler and settle disagreement between strategic partner and their Notified Body. Competent Authority ruled on behalf of the strategic partnership confirming Class I status.

Provided guidance to strategic partner regarding infusion pump regulatory strategy used as part of a drug device combination after EU Health Authorities rejected original strategy. Worked collaboratively with the strategic partner to obtain CE Mark in a six-month time frame.

Developed coaching program for medical device regulatory staff as part of biotech company regulatory affairs department. Coaching program outlines each regulatory position, the skills required for each level as well as the skills necessary to advance to the next level in the organization. This was the first medical device-coaching program in the organization.

E X P E R I E N C E

DCT Ltd, Watertown, MA 2009-present

Principal

Provide strategic guidance to clients in any phase of medical device and combination product development during both pre and post approval product lifecycle

Act as a liaison between the client organization and regulatory authorities worldwide

Prepare and file necessary regulatory submissions

STERNGOLD DENTAL, LLC, Attleboro, MA 2018-2019

Senior Manager, QUALITY ASSURANCE and REGULATORY AFFAIRS

Regulatory lead for dental device company.

Manage five technical files for dental implants, prosthetics, instruments to support product registrations worldwide.

INSULET CORPORATION, Billerica, MA 2016-2017

Senior Manager, REGULATORY AFFAIRS and QUALITY ASSURANCE for DRUG DELIVERY

Regulatory lead for drug delivery division providing strategy and support to division and biotech industry partners in pursuit of product approval in global market.

Develop and manage Device Master File for drug delivery device to support regulatory submission for drug delivery biotechnology clients

Collaborate with and provide guidance to drug delivery clients regarding appropriate regulatory path for infusion pump technology both in EU and US from initiation of contract through product lifetime.

Manage design control activities with drug delivery clients

Provide product support during drug delivery client audits, EU and FDA audits on behalf of company and drug delivery clients.

MCCORMICK LIFESCIENCE CONSULTANTS, LLC, Lunenburg, MA 2009-2016

Senior Consultant, REGULATORY AFFAIRS

Provide regulatory support for medical device and combination product clients on behalf of McCormick LifeScience Consultants, LLC. Activities included:

Develop and implement a strategic plan for an infusion pump on behalf of a drug delivery client

Maintain and submit regulatory filings for US, EU and Canadian market on behalf of an orthopedic company manufacturing Nano crystalline calcium phosphate biomaterials for bone repair and regeneration needs.

Provide a strategic plan for developing and submitting a regulatory submission and achieving market clearance for a below the knee prosthesis on behalf of an EU based client.

Collaborate with client of appropriate regulatory strategy for US client in early stages of development of a neurology device.

COVIDIEN BIOSURGERY, INC., Waltham, MA 2007-2009

Manager, REGULATORY AFFAIRS

Draft regulatory submissions pre and post approval for worldwide market.

Collaborate with R&D, Clinical, and Quality functions to execute regulatory strategy successfully from product inception to product launch.

Develop, document, and implement regulatory strategy for new technologies and product modifications.

Additional regulatory and clinical experience includes:

ALKERMES, INC., Cambridge, MA

Associate Director, REGULATORY AFFAIRS

BIOREG ASSOCIATES, Beltsville, MD

Senior Specialist, REGULATORY AFFAIRS

SYNTHES SPINE, Paoli, PA

Manager, REGULATORY AFFAIRS

MEDCHEM PRODUCTS, INC., Woburn, MA

Manager, Regulatory Affairs

USCI®, A DIVISION OF C.R. BARD, INC., Billerica, MA

Regulatory Affairs Coordinator

SYMBION, INC., Salt Lake City, UT

Clinical Research Associate, Technical Support, INERAID® Artificial Hearing Device

NEW HAVEN HEARING AND SPEECH CENTER, New Haven, CT

Audiologist

EAR, NOSE AND THROAT ASSOCIATES OF WATERBURY, P.C., Waterbury, CT

Audiologist

E D U C A T I O N

ITHACA COLLEGE, Ithaca, NY

Master of Science

Major: Audiology

UNIVERSITY OF CONNECTICUT, Storrs, CT

Bachelor of Arts

Major: Speech Pathology

Minor: Audiology

C O N T I N U I N G

E D U C A T I O N

BSI Roadshow, BSI, Waltham, MA

Developing a Business Plan, Center for Women in Enterprise, Boston, MA

Cash Flow Management, Center for Women in Enterprise, Boston, MA

Leadership Success Series, Healthcare Businesswomen’s Association, Boston, MA

Introduction to Pharmaceutical Marking and Promotion Seminar, Lucy Rose and Associates, Philadelphia, PA

Stat a Matrix Group Lead Assessor Training

S P E A K I N G

E N G A G E M E N T S

Presenter, RAPS Chapter Meeting, July 2009, Bentley College, Waltham, MA, sponsored by the Regulatory Affairs Professionals Society

Presenter, Regulatory Affairs Certification Exam Preparation Course, March 2009, Clinton, MA, sponsored by Boston Chapter of the Regulatory Affairs Professionals Society

Moderator, RA P S Annual Meeting, September 2007, Boston, MA sponsored by the Regulatory Affairs Professionals Society

Presenter, RAPS Horizons Conference, March 2006, San Diego, CA sponsored by the Regulatory Affairs Professionals Society

Track Chair, RAPS Annual Meeting, October 2005, Baltimore, MD sponsored by the Regulatory Affairs Professionals Society

Presenter, RAPS Annual Meetings, October 2003 -2005, Baltimore, MD, Washington, DC sponsored by the Regulatory Affairs Professionals Society

Presenter, Clinical Trials Conferences, August 2002 and April 2003, Washington, DC, San Diego, CA, sponsored by the Regulatory Affairs Professionals Society

P R O F E S S I O N A L

A F F I L I A T I O N S

Regional Director, Optics and Analytics, Corporate Relations, New England Region, Healthcare Businesswomen’s Association

Admissions Advisory Committee, Atrium School, Watertown, MA

Board of Direct0rs, Casa Myrna Vasquez, Inc., Boston, MA (2009-2015)

Adjunct Faculty, Northeastern University, College of Professional Studies, Boston, MA (2007-2013)

Committee Member, Leadership Success Series Committee, Volunteer Engagement, Boston Chapter Healthcare Businesswomen’s Association

Editorial Advisory Board member, Medical Device and Diagnostic Industry (MDDI) monthly Magazine, Canon Communications, Los Angeles, CA

Boston Chapter Chair, Regulatory Affairs Professionals Society (2004-2007)

Member, Ethics Core Task Force, Regulatory Affairs Professionals Society, 2003

Member, Editing Staff of Fundamentals of Regulatory Affairs 2001 Guide, published by the Regulatory Affairs Professionals Society

P R O F E S S I O N A L

M E M B E R S H I P S

Healthcare Businesswomen’s Association

Regulatory Affairs Professionals Society

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