Director Of Regulatory And Program Management
Current
Jan 2023 - Present
AeroLeads people directory · profile
Rene' Hardee Email & Phone Number
Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast
at
MedSec
1 work email found
@hologic.com
10 phones found area 321, 615, 217, and 865
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast
Location
Rockledge, Florida, United States
Who is Rene' Hardee? Overview
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Quick answer
Rene' Hardee is listed as Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast at MedSec, based in Rockledge, Florida, United States. AeroLeads shows a work email signal at hologic.com, phone signal with area code 321, 615, 217, 865, and a matched LinkedIn profile for Rene' Hardee.
Rene' Hardee previously worked as Director of Regulatory and Program Management at Medsec and Sr. Manager Regulatory Affairs at Medsec. Rene' Hardee holds Ms, Physics from Vanderbilt University.
Company email context
Email format at MedSec
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{first}.{last}@hologic.com
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Profile bio
About Rene' Hardee
Regulatory Affairs Director with extensive experience in the Medical Device industry.My passion is to help Medical Device Manufactures navigate the multiple laws and regulations of the world market and find a legal pathway for their devices to reach patients, all while remaining inside business constraints. My cross-functional experience in R&D, Quality Systems, Regulatory Submissions, and Regulatory Intelligence along with my scientific background and strong business acumen, enables a deeper understanding of the various challenges that need addressing in medical device product development and marketing.Key skills include:• Global Regulatory Intelligence• Global Cybersecurity Regulations• Trade Organization participation• Product Strategy• Global Device Registrations• 510k Submissions/ Letters to File• FDA, Health Canada, TGA, ANVISA, and EU Notified Body interactions (pre/post market)• Clinical Evaluation Report (CER) authoring to MEDDEV - 2.7.1 Rev 4 • UDI implementation• Chemical Compliance (REACH/RoHS/Conflict Minerals)• Recalls, MDRs, Responses to Inspections• Auditing ISO 13485• CAPA Coordinator• Project Management
Listed skills include Iso 13485, Fda, Capa, Medical Devices, and 42 others.
Current workplace
Rene' Hardee's current company
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11 roles
Rene' Hardee work experience
A career timeline built from the work history available for this profile.
Sr. Manager Regulatory Affairs
Your solution to meeting Medical Device Global Cybersecurity Regulations.
Jan 2023 - May 2023
Regulatory Affairs Manager
- Specific Accomplishment:
- Developed, implemented, and managed pro-active Global Regulatory Intelligence Program giving Hologic a competitive market advantage and preventing non-compliance incidentsLeadership Roles:
- 3 years organizing and leading Team Hologic in the Global Volunteer event - Jimmy Fund Walk Your Way, unifying and engaging the organization to further the #OneHologic mission
- Co-Led the Global RAQA Convergence Bi-Monthly meeting providing a centralized forum for delivering engaging and insightful content to unify the RAQA Organization
- Designed and moderated the 2022 RAQA Empowered Women Conversation sparking an important discussion and highlighting our women in Leadership
- Leader in the first HBA Hologic Ambassadors Program and enlisted in the Executive Committee to help pilot the program, paving the pathway for future women Ambassadors
Aug 2020 - Jan 2023
Sr. Global Regulatory Affairs Compliance Specialist
- Specific Accomplishments:
- Developed and implemented Hologic’s cross-functional, cross-Divisional Chemical Compliance Program for 2 years creating the necessary building blocks for a sustainable program
- Stabilized and significantly improved home-grown Regulatory Registration System (RRS) to provide Regulatory an essential tool to maintain a core function and remain compliant.
Apr 2018 - Aug 2020
Sr. Regulatory Affairs Specialist
- Specific Accomplishments:
- Effectively led a cross-departmental team over 1.5 years to implement the Unique Device Identification (UDI) program 6 weeks ahead of the compliance date
- SunCHECK Software 510k clearance (K170307)
- Prepared 6 other 510ks (not submitted)
- Partnered with Regional/Distributor contacts for successful global submissions
- Led FDA and BSI Audit Preparedness Teams using front-room/back-room methodology
Apr 2016 - Apr 2018
Regulatory Affairs Specialist
- Specific Accomplishments:
- DoseCHECK Software 510k clearance within 60 days of submission (K161946)
- Implemented a Regulatory Plan as a Phase I design deliverable to include Regulatory Affairs as a strategic partner to the business
- Led FDA and BSI Audit Preparedness Teams using front-room/back-room methodology
Apr 2015 - Apr 2016
Quality Specialist
- Specific Accomplishments:
- Streamlined CAPA Process providing a more effective and efficient system
- Designed and implemented Cost of Quality Program providing valuable financial insight to Leadership
- Designed and implemented Supplier Report Card Program saving the company hundreds of thousands of dollars
Sep 2011 - Apr 2015
Associate Project Manager
- Created, monitored, and managed project plans, project risks, and resource requirements
- Led design reviews, tactical development status reviews, and cross-functional project reviews
- Managed prototyping, sampling, and pilot production build, assembly, and test schedules
- Ensured proper and timely verification and validation activities and manage associated required resources
- Ensured proper design documentation including but not limited to requirements, design reviews, risk analysis, verification and validation plans and reports, as well as design history
- Supported the product launch team in manufacturing transfer and product launch activitiesLeadership Responsibilities:
Jan 2011 - Sep 2011
Research Assistant
- Collected and reduced data from Linear Accelerators.
- Analyzed data in support of Sr. Physicist projects
- Wrote succinct reports on findings and analysis in a clear, organized, and efficient manner.
- Assisted in the verification and validation process as needed.
- Performed various administrative duties in support of the Sr. Physicists.
Dec 2008 - Jan 2011
Crossfit Level 1 Trainer
Harbor City Crossfit
- Certified Starting Strength Coach
- Provided group and individual specialized training to athletes
- Customized client training to help set and achieve goals
- Motivated clients to continuously improve
Nov 2010 - Apr 2015
Data Reduction Analyst Professional
Computer Sciences Raytheon
- Performed data analysis and reduction of real-time Eastern Range Safety and data processing systems in support of missile launch requirements.
- Analyzed and evaluated incoming launch data from Radar, Telemetry, Command, and Optics sites throughout the Eastern Range.
- Operated critical real-time console in support of all phases of expendable, ballistic, and Shuttle launch operations.
- Identified, reported, and resolved anomalous events in a timely manner.
Jun 2005 - Oct 2008
3 education records
Rene' Hardee education
Ms, Physics
Vanderbilt University
Bs, Astrophysics
Florida Institute Of Technology
Education record
Florida Institute Of Technology
FAQ
Frequently asked questions about Rene' Hardee
Quick answers generated from the profile data available on this page.
What company does Rene' Hardee work for?
Rene' Hardee works for MedSec.
What is Rene' Hardee's role at MedSec?
Rene' Hardee is listed as Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast at MedSec.
What is Rene' Hardee's email address?
AeroLeads has found 1 work email signal at @hologic.com for Rene' Hardee at MedSec.
What is Rene' Hardee's phone number?
AeroLeads has found 10 phone signal(s) with area code 321, 615, 217, 865 for Rene' Hardee at MedSec.
Where is Rene' Hardee based?
Rene' Hardee is based in Rockledge, Florida, United States while working with MedSec.
What companies has Rene' Hardee worked for?
Rene' Hardee has worked for Medsec, Hologic, Inc., Sun Nuclear Corporation, Harbor City Crossfit, and Computer Sciences Raytheon.
How can I contact Rene' Hardee?
You can use AeroLeads to view verified contact signals for Rene' Hardee at MedSec, including work email, phone, and LinkedIn data when available.
What schools did Rene' Hardee attend?
Rene' Hardee holds Ms, Physics from Vanderbilt University.
What skills is Rene' Hardee known for?
Rene' Hardee is listed with skills including Iso 13485, Fda, Capa, Medical Devices, Process Improvement, Quality System, Quality Assurance, and Cross Functional Team Leadership.
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