Twin Cities Chapter In Person Event: Regulatory Rounds - Speed Mentoring

Registration Fees & Deadlines

Who Should Attend?

• Gain valuable mentorship and career insights.
• Build connections with leaders across the Minnesota regulatory community.
• Learn best practices and strategies to grow in your regulatory career.
• Those aspiring to move into Regulatory Affairs, Regulatory Affairs Specialists, Regulatory Affairs Coordinators, and Regulatory Affairs Managers.

This event is a meaningful way to develop professionally, expand your network, and get inspired by experienced leaders.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

• Welcome & Keynote (5:30 – 5:45 PM): Opening remarks and insights on the value of mentorship in regulatory affairs.
• Speed Mentoring Rounds (5:45 – 6:50 PM): Engage in focused 10-minute discussions with multiple mentors, sharing career guidance, best practices, and insights.
• Networking & Wrap-Up (6:50 – 7:30 PM): Build further connections and select a mentee for a six-month mentorship opportunity (one meeting per month).

Featured Mentors:

Amra Racic
VP, Global Government Strategy - Veeva MedTech

Amra has over 23 years of experience in healthcare, including regulatory roles at Abbott, Bayer, and Medtronic. She is an expert in global regulatory strategy, advocacy, and intelligence, with a passion for aligning business and regulatory goals to drive innovation.

Angelina Lisandrelli
Director of Regulatory and Quality - RespirTech, Philips

Angelina is a regulatory leader with expertise in FDA submissions, EU MDR compliance, quality systems, and software as a medical device (SaMD). She excels in preparing 510(k)s, PMAs, IDEs, and Q-Submissions, as well as advising on technical documentation for global standards compliance. Angelina is passionate about promoting patient safety, mentoring teams, and fostering cross-functional collaboration to drive regulatory success.

Djuana Banks
Regulatory Affairs Manager - Medtronic

Djuana is an experienced regulatory and clinical research professional with expertise in innovative strategies, cross-functional collaboration, and mentorship. She is known for effectively driving regulatory initiatives and providing data-driven insights for new and legacy products.

Kristen Evenson
Staff Regulatory Affairs Specialist - Hyperfine, Inc.

Kristen is a dynamic regulatory professional with extensive experience in FDA, EU, and global submissions. She combines strong organizational and project management skills with a passion for achieving timely regulatory approvals.

Lisa Pritchard
VP, Regulatory, Quality, Clinical & Engineering - DuVal & Associates

Lisa is a seasoned regulatory leader with expertise spanning regulatory strategy, submissions (Q-Subs, IDEs, 510(k), De Novo, PMA), quality systems, and clinical trial design. She has successfully led companies through 3 PMA advisory panels, resulting in unanimous FDA recommendations for approval and achieving multi-million-dollar product revenues.

Mark Swanson
Partner - QRx Partners

Mark is a recognized expert in Medical Device Quality Management Systems with extensive experience in global regulatory requirements, including FDA QSR, ISO 13485, and MDSAP. His career spans the entire product lifecycle, specializing in risk management, design and development, CAPA, and compliance with global standards.

Marielle Lejcher
Vice President, Regulatory Affairs and Quality - ZoaDx Corporation

Marielle has over 20 years of experience in in vitro diagnostics (IVDs), focusing on regulatory strategy, risk management, and FDA policy. She has held leadership roles across the medical device and diagnostics industry, with expertise in quality systems, biocompatibility, and international and US regulatory affairs.

Minori Carlsson
Head of Regulatory Affairs, Philips IGT-D

Based in Saint Paul, MN, Minori brings a wealth of experience from Medtronic and Philips. With expertise in medical devices, ISO 13485, and FDA regulations, Minori is a devoted leader focused on patient safety and advancing the regulatory profession.

Monika McDole Russell
Senior Director, Global Regulatory Affairs - Medtronic Endoscopy

Monika is an accomplished Regulatory Affairs leader with expertise in FDA submissions, Class II and Class III devices, and global regulatory requirements. She excels in building and guiding top-performing teams while driving organizational goals with outstanding communication and leadership skills.

Prithul Bom
President & CEO - Regulatory Technology Services

As the leader of an FDA-accredited Third-Party Review Organization (3PRO), Prithul brings 22 years of expertise across healthcare, medical devices, biotech, and IVDs. Prithul’s experience spans global regulatory leadership, clinical development planning, and advancing innovative imaging modalities and diagnostic agents.

Location

St. Cloud Plymouth Facility
9750 Rockford Rd
# 100
Plymouth, MN 55442

Platinum Chapter Sponsors 

MDSS 

RxTROSPECT

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing tobsupport@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions