Sangeetha Joseph
Joseph P. Liu
Joseph Liu is a Career Coach and Speaker specializing in career change and personal branding. He helps professionals relaunch their careers and find more meaningful work through consulting, workshops, and his podcast.
Joseph Liu is a dedicated Career Coach and Speaker with a mission to empower professionals to achieve more meaningful work. Drawing on his extensive background in global marketing and personal branding, Joseph guides individuals through significant career transitions. He offers a range of services including personal brand consulting, career change coaching, resume reviews, and speaking engagements. His expertise is further amplified through his popular "Career Relaunch®" podcast, recognized by Forbes and Glassdoor for its valuable insights into career development and entrepreneurship. Joseph's approach is informed by his own non-traditional career path, including his experience in brand management for major companies and his academic background in psychology and business. Joseph holds an MBA from the University of Michigan and an Associate Certified Coach (ACC) credential from the International Coach Federation. He has been featured in publications like Forbes and Fast Company, and has spoken at events such as TEDx. He is passionate about helping clients gain the clarity, confidence, and courage to navigate their career journeys and make a meaningful impact.
About
**Who they are**
Sangeetha Joseph is a Biomedical Engineer with over 3 years of experience in medical device R&D, Quality Assurance, and Regulatory Affairs, specializing in EU MDR/IVDR compliance. They are eligible to act as an External PRRC (Person Responsible for Regulatory Compliance) under EU MDR.
**Expertise & scope**
* EU MDR 2017/745 and IVDR 2017/746 compliance
* ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 10993, ISO 11607 standards
* Technical Documentation (Annex II/III) and EU Declarations of Conformity
* Post-Market Surveillance (PMS) and Vigilance
* Risk management, Change control, CAPA (Corrective and Preventive Actions)
* Audit readiness and lifecycle compliance
* Regulatory guidance and advisory for small/micro medical device projects
* Experience collaborating with clinicians, engineers, and stakeholders
**Reputation / proof points**
* Eligible to act as an External PRRC (Article 15, EU MDR)
* Hands-on expertise in key regulatory documentation and processes
Sangeetha Joseph is a Biomedical Engineer with over 3 years of experience in medical device R&D, Quality Assurance, and Regulatory Affairs, specializing in EU MDR/IVDR compliance. They are eligible to act as an External PRRC (Person Responsible for Regulatory Compliance) under EU MDR.
**Expertise & scope**
* EU MDR 2017/745 and IVDR 2017/746 compliance
* ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 10993, ISO 11607 standards
* Technical Documentation (Annex II/III) and EU Declarations of Conformity
* Post-Market Surveillance (PMS) and Vigilance
* Risk management, Change control, CAPA (Corrective and Preventive Actions)
* Audit readiness and lifecycle compliance
* Regulatory guidance and advisory for small/micro medical device projects
* Experience collaborating with clinicians, engineers, and stakeholders
**Reputation / proof points**
* Eligible to act as an External PRRC (Article 15, EU MDR)
* Hands-on expertise in key regulatory documentation and processes
Additional information
Sangeetha Joseph provides regulatory support for medical devices, focusing on EU MDR and IVDR compliance. This includes the preparation of essential technical documentation such as Annex II/III Technical Documentation and EU Declarations of Conformity. They also manage risk files, change control, and CAPA activities, ensuring products meet regulatory requirements throughout their lifecycle. Their services are particularly beneficial for small and micro medical device projects requiring expert regulatory guidance and audit preparation.
Buyer Snapshot
Best for
- Small and micro medical device manufacturers
- Companies seeking EU MDR/IVDR compliance support
- Businesses needing PRRC services
How engagement typically works
- Project-based regulatory consulting
- Advisory and guidance
- Documentation support
Typical deliverables
- Technical Documentation (Annex II/III)
- EU Declarations of Conformity
- Risk Management Files
- PMS and Vigilance plans
- Audit readiness support
Good to know
- Best when requiring specialized EU MDR/IVDR expertise.
- Focus on medical device regulatory affairs.
HQ:
Dublin, US
Languages:
English
Timezones:
UTC, EST
Status:
claimed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Coverage:
US, UK
Languages:
English
Pricing Basis:
custom
Supports Special Category Data:
No
Supports Children Data:
No
Supports Biometric Data:
No
Supports Health Data:
No
Dpa Available:
No
Subprocessor List Available:
No
Breach Notification SLA:
Custom
Dsar Workflow Support:
None
Regulator Comms Handling:
Forward only
