Peter Mincieli

Experienced regulatory affairs leader with extensive background in biopharmaceutical and drug development environments. Proven expertise in global regulatory submissions, including IND/CTA preparation for clinical trials, and comprehensive knowledge of FDA and international regulations. Demonstrated ability to manage and mentor regulatory affairs teams, oversee external vendors, and ensure compliance with evolving regulatory requirements.

Authorized to work in the United States and available for hybrid or remote work with travel to San Diego. Eager to contribute to Contineum Therapeutics' mission of advancing novel therapies.

V.P. Quality/ Regulatory - S20RTHO

(2006)

• Led regulatory strategy and submissions, including IND/CTA applications for clinical trials
• Guided company through applications of new devices to FDA
• Managed and mentored regulatory affairs personnel to achieve department goals
• Oversaw external vendors to ensure compliance and timely regulatory submissions
• Assisted in finalization of product design and packaging
• Authored and implemented new quality systems
• Monitored day-to-day regulatory and quality operations

V.P. Quality/ Regulatory (Contract) - Nutek Orthopaedics

(2017 - 2022)

• Directed regulatory affairs activities, including preparation of submissions for product approvals
• Finalized product design and packaging for compliance
• Managed sales tracking and regulatory documentation
• Supervised day-to-day regulatory operations and mentored team members

CEO - Biedermann Motech Inc.

(2015 - 2021)

• Finalized infrastructure and documentation for dynamic sales operation
• Acquired and managed talent across all functional departments
• Guided teams in implementing documentation for new processes
• Built functional groups and led them to operational success

Chief Operating Officer (COO) - MIAMI Decice Solutions

(2014 - 2014)

• Established operating infrastructure and departmental structure
• Implemented distribution system for implant/instrument sets
• Oversaw regulatory and quality compliance across departments

President - HealthLink Associates

(2014 - 2015)

• Initiated and managed medical device consulting operations
• Provided regulatory and quality assurance consulting for clients

Consultant - Miami Device Solutions

(2000 - 2000)

• Managed regulatory, quality, product design, and process improvement
• Authored and implemented full quality system for device production
• Wrote FDA application for first product approval
• Provided technical assessment for technology acquisitions

Senior Vice President - Z-KAT, Inc

(1991 - 1998)

• Led regulatory submissions for new devices to FDA
• Assisted in product design and packaging for compliance
• Authored new quality systems
• Monitored daily regulatory and quality operations

Director New Technology Development - Howmedica

(1986 - 1995)

• Oversaw development and regulatory review of new technologies

Assistant Director of New Manufacturing Technology - Howmedica

(1981 - 1991)

• Supported regulatory and manufacturing technology initiatives

Manager, Special Projects - Howmedica

(1981 - 1982)

• Managed special projects related to regulatory and manufacturing processes

Senior Manufacturing Engineer - Howmedica

(1981 - 1981)

• Contributed to regulatory and engineering projects in manufacturing

Degree - Mechanical Engineering - Newark College of Engineering