OR · On-site
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
OR · On-site
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
OR · On-site
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Redwood City, CA · On-site
$238.90K - $281.10K/yr
Direct experience with regulatory submissions to PMDA is desirable * Experience with small molecules is preferred * Experience in successfully leading assigned activities within cross-functional ...
Redwood City, CA · On-site
$238.90K - $281.10K/yr
Direct experience with regulatory submissions to PMDA is desirable * Experience with small molecules is preferred * Experience in successfully leading assigned activities within cross-functional ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
... PMDA in Japan. Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including commercial product specifications are met according to Health ...
... PMDA in Japan. Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including commercial product specifications are met according to Health ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Berkeley, CA · On-site
$175K - $195K/yr
Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA) * Lead preparation and authorship of CMC sections (Module 2.3, 3) for: * INDs ...
Quick apply
Berkeley, CA · On-site
$175K - $195K/yr
Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA) * Lead preparation and authorship of CMC sections (Module 2.3, 3) for: * INDs ...
Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements. * Experience contributing to CMC regulatory filings is desirable. * Strong ...
Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements. * Experience contributing to CMC regulatory filings is desirable. * Strong ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Essential Functions: 1. Perform manufacturing processes and operate production ...
In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Essential Functions: 1. Perform manufacturing processes and operate production ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Minnetonka, MN · On-site
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
Minnetonka, MN · On-site
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...
Boston, MA · Hybrid
... PMDA), including defending strategies and leading regulatory responses Collaborate cross-functionally and serve as a key partner to Program Strategy Teams Provide oversight of external partners ...
Boston, MA · Hybrid
... PMDA), including defending strategies and leading regulatory responses Collaborate cross-functionally and serve as a key partner to Program Strategy Teams Provide oversight of external partners ...
Cambridge, MA · Remote
Represent the company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses to queries on RLT topics. Compliance Oversight: Ensure all submissions comply with ICH, GMP, and ...
Quick apply
Cambridge, MA · Remote
Represent the company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses to queries on RLT topics. Compliance Oversight: Ensure all submissions comply with ICH, GMP, and ...
San Francisco, CA · Hybrid
$160K - $180K/yr
Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR. * Team Guidance: Provide technical coaching and quality training to R&D ...
San Francisco, CA · Hybrid
$160K - $180K/yr
Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR. * Team Guidance: Provide technical coaching and quality training to R&D ...
San Mateo, CA · On-site
$340K - $370K/yr
Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements * Demonstrated ability to manage complex, cross ...
San Mateo, CA · On-site
$340K - $370K/yr
Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements * Demonstrated ability to manage complex, cross ...
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
San Mateo, CA · On-site
$340K - $370K/yr
Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements * Demonstrated ability to manage complex, cross ...
San Mateo, CA · On-site
$340K - $370K/yr
Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements * Demonstrated ability to manage complex, cross ...
$17.31 - $19.67
6% of jobs
$21.49 is the 25th percentile. Wages below this are outliers.
$19.67 - $22.03
24% of jobs
$22.03 - $24.39
17% of jobs
The median wage is $24.98 / hr.
$24.39 - $26.75
11% of jobs
$26.75 - $29.11
6% of jobs
$30.62 is the 75th percentile. Wages above this are outliers.
$29.11 - $31.47
17% of jobs
$31.47 - $33.83
7% of jobs
$33.83 - $36.19
4% of jobs
$36.19 - $38.55
6% of jobs
$38.55 - $40.91
1% of jobs
$40.91 - $43.27
0% of jobs
$17
$27
$43
| Aspect | Pmda | Pharmacist |
|---|---|---|
| Required Credentials | Typically requires a specialized certification or training in medical device regulation | Requires a pharmacy degree and licensure |
| Work Environment | Regulatory agencies, medical device companies, healthcare compliance | Community pharmacies, hospitals, healthcare settings |
| Industry Usage | Regulatory and compliance sectors within healthcare | Pharmaceuticals, healthcare, patient care |
While Pmda professionals focus on medical device regulation and compliance, pharmacists are licensed healthcare providers specializing in medication dispensing and patient care. Both roles are vital in healthcare but serve different functions and require distinct credentials.

Full-time
Posted 16 days ago
7.7
Based on 389 frontline employees who took The Breakroom Quiz
185th of 512 rated manufacturers
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Regulatory Affairs Manager you'll provide strategic guidance on regulatory pathways, manage submissions, and serve as a subject matter expert on various regulations across multiple jurisdictions. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities. This position offers excellent opportunities for growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
REQUIREMENTS:
• Bachelor's Degree plus 5 years of experience in regulatory affairs in IVD/medical device industry
• Preferred Fields of Study: Biology, Chemistry, Bioengineering, or related scientific field
• Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies)
• Experience preparing and managing regulatory submissions (510(k), PMA, CE marking, technical documentation)
• Strong knowledge of quality management systems (ISO 13485, GMP, QSR)
• Demonstrated success in regulatory strategy development and implementation
• Experience leading regulatory aspects of product development teams
Knowledge, Skills, Abilities
• Excellent project management and organizational skills
• Strong analytical and problem-solving abilities
• Outstanding written and verbal communication skills
• Ability to interpret and communicate complex regulatory requirements
• Experience with risk management and post-market surveillance activities
• Proficiency in reviewing technical documentation and product labeling
• Ability to work effectively in a matrix organization
• Strong interpersonal skills and ability to build consensus
• Willingness to travel (10-15% typically)
• Ability to adapt to evolving regulatory landscape
• Proficiency with standard office software and regulatory documentation systems
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
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Biotechnology research and development
10,000+ Employees
Waltham, MA, US
1956