Mary Donlin Email & Phone Number | Experienced regulatory affairs professional with 10+ years of management experience. Effective communicator experienced managing FDA 510(k) submissions and CAPA process initiatives. Proven track record of success developing high-performance strategic relationships between the company, key accounts and major customers. Accustomed to extensive domestic and international travel. PROFILE •Strong technical and management background. Experienced organizing and leading med-tech projects to meet deadlines for global commercialization, with budgets to 2.4M and teams of up to 20 personnel. •Superior communication skills. Experienced delivering high-level presentations to groups of up to 200 physicians, scientists, international thought leaders, executives and FDA officials. •Experienced regulatory affairs professional. Filed multiple FDA 510(k) pre-market notifications -- first successful filings in 10 years at Medical Graphics (2006 and 2007). •Vice President of R&D said: “Mary is an essential part of our management team. She has proven her ability to multi-task and drive projects. Her work ethic and commitment are exceptional.” (2007) Specialties: Regulatory affairs 510(k) submissions ISO 13485 QSM Audits

Mary Donlin

Experienced regulatory affairs professional with 10+ years of management experience. Effective commu...
St Paul, Minnesota, United States

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Mary Donlin’s Phone Numbers +1 847-948-****

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Mary Donlin’s Location St Paul, Minnesota, United States

Mary Donlin’s Current Industry Diagnostic Cardiology At Baxter

Mary Donlin’s Prior Industry Baxter International | Hillrom | Admedus | Medtronic | Medical Graphics

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Associate Director Regulatory Affairs

2024-07-01 00:00:00 - Present

Sr Manager Regulatory Affairs

2021-12-01 00:00:00 - 2024-07-01 00:00:00

Sr Manager Regulatory Affairs

2020-04-01 00:00:00 - 2021-12-01 00:00:00

Vice President Regulatory Affairs and Compliance

2014-03-01 00:00:00 - 2019-07-01 00:00:00

Principal Regulatory Affairs Specialist

2013-06-01 00:00:00 - 2014-02-01 00:00:00

Senior Product Development Manager

2005-02-01 00:00:00 - 2008-05-01 00:00:00

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Mary Donlin is a Experienced regulatory affairs professional with 10+ years of management experience. Effective communicator experienced managing FDA 510(k) submissions and CAPA process initiatives. Proven track record of success developing high-performance strategic relationships between the company, key accounts and major customers. Accustomed to extensive domestic and international travel. PROFILE •Strong technical and management background. Experienced organizing and leading med-tech projects to meet deadlines for global commercialization, with budgets to 2.4M and teams of up to 20 personnel. •Superior communication skills. Experienced delivering high-level presentations to groups of up to 200 physicians, scientists, international thought leaders, executives and FDA officials. •Experienced regulatory affairs professional. Filed multiple FDA 510(k) pre-market notifications -- first successful filings in 10 years at Medical Graphics (2006 and 2007). •Vice President of R&D said: “Mary is an essential part of our management team. She has proven her ability to multi-task and drive projects. Her work ethic and commitment are exceptional.” (2007) Specialties: Regulatory affairs 510(k) submissions ISO 13485 QSM Audits

Mary Donlin has prior
experience in the following industries:
Baxter International | Hillrom | Admedus | Medtronic | Medical Graphics

Mary Donlin has the following professional experience:
Diagnostic Cardiology At Baxter | Baxter International | Hillrom | Admedus | Medtronic | Medical Graphics