Rene' Hardee

Rene' Hardee Email and Phone Number

Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast @ MedSec
Rene' Hardee's Location
Rockledge, Florida, United States, United States
Rene' Hardee's Contact Details
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

Rene' Hardee's Current Company Details
MedSec

Medsec

View
Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast
Rene' Hardee Work Experience Details
  • Medsec
    Director Of Regulatory And Program Management
    Medsec Jan 2023 - Present
    Miami Beach, Florida, Us
    View
  • Medsec
    Sr. Manager Regulatory Affairs
    Medsec Jan 2023 - May 2023
    Miami Beach, Florida, Us
    Your solution to meeting Medical Device Global Cybersecurity Regulations.
    View
  • Hologic, Inc.
    Regulatory Affairs Manager
    Hologic, Inc. Aug 2020 - Jan 2023
    Marlborough, Ma, Us
    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 • Led a team to create a Mentorship Landing Page on the HR Talent and Performance Site to provide key resources for Hologic employee career growth
    View
  • Hologic, Inc.
    Sr. Global Regulatory Affairs Compliance Specialist
    Hologic, Inc. Apr 2018 - Aug 2020
    Marlborough, Ma, Us
    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.
    View
  • Sun Nuclear Corporation
    Sr. Regulatory Affairs Specialist
    Sun Nuclear Corporation Apr 2016 - Apr 2018
    Melbourne, Florida, Us
    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
    View
  • Sun Nuclear Corporation
    Regulatory Affairs Specialist
    Sun Nuclear Corporation Apr 2015 - Apr 2016
    Melbourne, Florida, Us
    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
    View
  • Sun Nuclear Corporation
    Quality Specialist
    Sun Nuclear Corporation Sep 2011 - Apr 2015
    Melbourne, Florida, Us
    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
    View
  • Sun Nuclear Corporation
    Associate Project Manager
    Sun Nuclear Corporation Jan 2011 - Sep 2011
    Melbourne, Florida, Us
    • 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:• Monitored and enforce accountabilities within project teams• Inspired creative and innovative thinking from team members while respecting individual ideas and contributions
    View
  • Sun Nuclear Corporation
    Research Assistant
    Sun Nuclear Corporation Dec 2008 - Jan 2011
    Melbourne, Florida, Us
    • 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.
    View
  • Harbor City Crossfit
    Crossfit Level 1 Trainer
    Harbor City Crossfit Nov 2010 - Apr 2015
    • 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
  • Computer Sciences Raytheon
    Data Reduction Analyst Professional
    Computer Sciences Raytheon Jun 2005 - Oct 2008
    • 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.

Rene' Hardee Skills

Iso 13485 Fda Capa Medical Devices Process Improvement Quality System Quality Assurance Cross Functional Team Leadership Corrective Actions Root Cause Analysis Manufacturing Continuous Improvement Medical Imaging R&d Integration Quality Auditing V&v Leadership U.s. Food And Drug Administration Preventive Actions Requirements Analysis Iso 9000 Technical Writing Corrective And Preventive Action Risk Assessment Internal Audit Training Quality Management Design Control Validation Cost Of Quality Kaizen Lean Manufacturing Research And Development 21 Cfr 820/qsr 21 Cfr 803/mdr Trend Analysis Asq Member Data Analysis Supplier Quality Team Leadership Verification And Validation Business Process Improvement 21 Cfr 806/recall Compliance 5 Whys

Rene' Hardee Education Details

  • Vanderbilt University
    Vanderbilt University
    Physics
  • Florida Institute Of Technology
    Florida Institute Of Technology
    Astrophysics
  • Florida Institute Of Technology
    Florida Institute Of Technology

Frequently Asked Questions about Rene' Hardee

What company does Rene' Hardee work for?

Rene' Hardee works for Medsec

What is Rene' Hardee's role at the current company?

Rene' Hardee's current role is Perpetual Learner| Life Optimizer| Genuine Leader| Social Advocate| Community Enthusiast.

What is Rene' Hardee's email address?

Rene' Hardee's email address is re****@****gic.com

What is Rene' Hardee's direct phone number?

Rene' Hardee's direct phone number is +132154*****

What schools did Rene' Hardee attend?

Rene' Hardee attended Vanderbilt University, Florida Institute Of Technology, Florida Institute Of Technology.

What are some of Rene' Hardee's interests?

Rene' Hardee has interest in Personal Finance, Leadership Training, Regulatory, Nutrition, Tiny Houses, Management Training, Modular/multi Purpose Furniture, Efficiency, Psycology, Crossfit.

What skills is Rene' Hardee known for?

Rene' Hardee has skills like Iso 13485, Fda, Capa, Medical Devices, Process Improvement, Quality System, Quality Assurance, Cross Functional Team Leadership, Corrective Actions, Root Cause Analysis, Manufacturing, Continuous Improvement.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.