Archana Ranganathan
Livermore,United States
Summary
Dynamic and strategic regulatory affairs professional with a proven track record in delivering comprehensive analysis, preparation, and review of essential documentation to facilitate timely approvals for global product development. A solid educational background in physics and biophysics underpins a deep understanding of complex technical concepts, enabling effective regulatory guidance. Expertise in anticipating regulatory risks and emerging issues throughout the product lifecycle ensures robust compliance and supports organizational objectives. Committed to fostering collaboration across teams to drive successful outcomes in highly regulated environments.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Senior Manager
Abbott Heart Failure
Pleasanton, CA
01.2012 - Current
- Achieved successful product launches by collaborating with cross functional teams throughout the development process.
- Collaborated with cross-functional teams to drive strategic initiatives and operational improvements in Heart Failure.
- Drove regulatory strategy formulation in collaboration with Abbott International Regulatory Affairs for International product registrations/launches.
- Overseeing a team of 8 regulatory affairs professionals to enhance operational efficiency. Supervised contractors to ensure compliance with regulatory standards. Mentored interns to foster their growth and skill development.
- Provided strong leadership to enhance team productivity and morale.
- Mentored junior staff members for skill development and career progression within the organization.
- Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
Regulatory Affairs Specialist
Boston Scientific
Fremont, CA
01.2007 - 2012
- Prepared submissions to obtain and maintain global regulatory approvals for commercial distribution of ultrasound imaging products. Collaborated with global RA staff and provided regulatory guidance to cross-functional teams.
- Facilitated global regulatory compliance by delivering comprehensive documentation and input for design and engineering modifications of commercialized products.
- Achieved CE mark maintenance for product line through effective management. Completed certification renewal project for Class III devices, ensuring continued market access.
- Facilitated collaboration with Japanese counterparts to define detailed submission requirements for commercialized products and new product development.
- Directed regulatory strategy development for new and existing products across Asia-Pacific, South America, Africa, the Middle East, Canada, and Eastern Europe. Led teams in producing content for U.S. and international regulatory submissions. Analyzed U.S. and Health Canada regulatory requirements to ensure compliance with Health Canada licenses and FDA clearances.
Education
Master of Business Administration - MBA
San Jose State University
San Jose, CAM.Sc. - Clinical and Veterinary Medicine
University of Cambridge, Herchel Smith Laboratory For Medicinal Chemistry
United KingdomSkills
- Strategic development
- Multidisciplinary engagement
- Workflow efficiency
- Multi-team project coordination
Accomplishments
- Authored critical sections of an original PMA (Verification & Validation and Sterilization), reviewed key documentation, and supported responses to FDA deficiencies.
- Prepared and obtained approval for a less invasive surgical approach for implantation of the Mechanical Circulatory Support Device.
- Led regulatory strategy and submissions for a new set of surgical tools to support device implantation, serving as RA core team member from project initiation through launch.
- Secured approval for an extremely critical supplier change affecting an implanted component of the Mechanical Circulatory Support Device.
- Achieved approval for a pediatric indication for the Mechanical Circulatory Support Device in Canada.
- Led cross‑functional teams to obtain approvals for business‑critical changes that mitigated supply‑chain risks and ensured continued global product availability.
- Directed successful submissions for APAC renewals, registrations, and market approvals.
- Guided teams in developing tools and training to support product release authorization.
- Played a key role in bringing regulatory files into compliance with a significantly revised Medical Device Directive.
Affiliations
Regulatory Affairs Professional Society, member
Certification
RAC-US Certified
Timeline
Regulatory Affairs Senior Manager
Abbott Heart Failure
01.2012 - Current
Regulatory Affairs Specialist
Boston Scientific
01.2007 - 2012
Master of Business Administration - MBA
San Jose State University
M.Sc. - Clinical and Veterinary Medicine
University of Cambridge, Herchel Smith Laboratory For Medicinal Chemistry
Profile
- Johns Hopkins University / National Institutes of Health, Baltimore, MD, Research Fellow
- Recipient of multiple scholarships, awards, and endowments for both undergraduate and graduate studies.
- Recipient of multiple excellence awards for providing critical submission and project support.