Desired Job Title
Quality EngineerRegulatory Affairs SpecialistRegulatory Affairs Specialist – International RegistrationsLocation Preference
On-SiteRemoteHybridLocation: East Taunton, USASoutheastern MAProvidence, RI
Open to relocation: No
Open To Work
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SUZANNE CREHAN
East Taunton,USA
Work Preference
Summary
Results-driven Life Sciences professional specializing in global product registrations and post-market quality in regulated environments. Led portfolio-wide re-registration initiatives, identifying compliance gaps and implementing solutions for market expansion. Contributed to IVDR implementation by developing Post-Market Surveillance Plans accepted on first submission. Enhanced operational efficiency through a centralized Regulatory Affairs SharePoint platform, streamlining workflows and reducing license-renewal processing time.
Overview
1
1
Certification
10
10
years of professional experience
Work History
Quality Engineer
Siemens Healthcare Diagnostics, Inc. (Point-of-Care)
Walpole, MA
09.2022 - 02.2026
- Led post-market surveillance (PMS) activities to ensure ongoing product safety, performance, and regulatory compliance with FDA, ISO 13485, and EU MDR requirements
- Analyzed post-market data, including complaints, adverse events, and nonconformances to identify trends and potential quality signals
- Conducted root cause investigations and implemented corrective and preventive actions (CAPA) to address field issues
- Prepared and maintained PMS reports, including trend analyses and PSURs, to inform management decisions and enhance product safety monitoring
- Supported regulatory reporting activities such as Medical Device Reporting (MDR) and vigilance submissions
- Collaborated with Regulatory Affairs, R&D, Manufacturing, and Clinical teams to assess product risk and implement quality improvements
- Utilized statistical tools and data analysis techniques to identify quality trends and support continuous improvement initiatives
- Ensured all documentation was accurate, complete, and audit-ready in compliance with quality management system requirements
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics, Inc. (Point-of-Care)
Walpole, MA
03.2018 - 09.2022
- Prepared, compiled, and submitted regulatory dossiers in compliance with international requirements (e.g., EU MDR/IVDR, Health Canada, ANVISA, PMDA, TGA)
- Managed global product registrations and market authorizations across regions, including the EU, Canada, Latin America, and Asia-Pacific
- Coordinated with international regulatory authorities, notified bodies, and in-country representatives to facilitate timely approvals of product registrations
- Monitored and interpreted global regulatory changes to ensure compliance, advising internal teams on implications for product strategy
- Collaborated cross-functionally with Quality, R&D, Clinical, and Manufacturing to gather documentation and support submissions
- Managed renewal, variation, and change notifications for existing international registrations
- Tracked submission timelines and maintained regulatory databases, ensuring accuracy and currency of records to support compliance efforts
- Participated in audits and inspections, providing regulatory support and documentation.
Regulatory Affairs Specialist – International Registrations
Johnson & Johnson (Depuy-Syntheses)
Raynham, MA
08.2016 - 03.2018
- Managed global product registrations and market authorizations across regions, including EU, Canada, Latin America, and the Asia-Pacific
- Coordinated with international regulatory authorities, notified bodies, and in-country representatives to secure timely product approvals
- Maintained regulatory documentation, including technical files, design dossiers, and country-specific registration requirements to ensure compliance and facilitate approvals
- Managed renewal, variation, and change notifications for existing international registrations
- Maintained regulatory documentation, including technical files, design dossiers, and country-specific registration requirements
- Tracked submission timelines and updated regulatory databases to ensure accurate records and support efficient registration processes
Skills
- Quality Improvement
- GMP documentation
- Root cause analysis
- Statistical Analysis
- Streamlining Processes
- Technical organization
- Strategic Project Management
- Adaptability & Prioritization
- Collaborative contributor
- Communication proficiency
Accomplishments
- By 9%; increased Siemens POC global market share by leading a complex portfolio-wide re-registration project
- By 33%; reduced amount of time to secure timely product license renewals by creating a SharePoint with all the commonly requested document automating i.e. creating, designing, and populating a SharePoint that loaded the common and essential documentation for the regions to share.
- Delivered 100% on-time certifications for new and legacy product portfolios by serving as core team RA/Quality representative for post-market activities, coordinating technical documentation and cross-functional responses.
- Delivered 100% pass rate / 0 (Zero) audit findings during regulatory inspections by demonstrating strict adherence to GMP documentation and revision control on highly regulated documents and quality records.
- Delivered 100% compliance with global regulatory requirements by implementing a systematic Post-Market Surveillance (PMS) reporting schedule
Certification
Massachusetts Notary Public (My Commission expires October 2031)
Timeline
Quality Engineer
Siemens Healthcare Diagnostics, Inc. (Point-of-Care)
09.2022 - 02.2026
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics, Inc. (Point-of-Care)
03.2018 - 09.2022
Regulatory Affairs Specialist – International Registrations
Johnson & Johnson (Depuy-Syntheses)
08.2016 - 03.2018