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Biology, Chemistry, Bioengineering, or related scientific field • Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies) • ...

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 ...

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 ...

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 ...

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 ...

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$17

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$43

How much do pmda jobs pay per hour?

As of Jun 1, 2026, the average hourly pay for pmda in the United States is $27.37, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $31.01 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a PMDA (Pharmaceuticals and Medical Devices Agency) reviewer, and why are they important?

To thrive as a PMDA reviewer, you need an advanced degree in pharmaceutical sciences, medicine, or related fields, along with a thorough understanding of drug development and regulatory requirements. Familiarity with regulatory submission systems, guideline databases, and scientific data analysis tools is essential. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for this role. These competencies ensure rigorous evaluation of medical products, safeguard public health, and facilitate clear interactions with stakeholders.

What are some common challenges faced by a PMDA (Project Management Data Analyst), and how can they be addressed?

One common challenge for a PMDA is balancing the need for timely project updates with ensuring data accuracy and consistency across multiple sources. Since PMDAs often work with cross-functional teams, aligning everyone on standardized data reporting processes can be demanding. Building strong communication channels and implementing robust data validation tools can help overcome these challenges. Additionally, proactively seeking feedback from stakeholders and regularly updating documentation can streamline workflows and support project success.

What are PMDA and what do they do?

PMDA stands for Pharmaceuticals and Medical Devices Agency, which is a Japanese government agency responsible for reviewing, approving, and monitoring pharmaceuticals, medical devices, and regenerative medicines. They ensure the safety, efficacy, and quality of these products before and after they enter the Japanese market. PMDA also provides consultation services during the development process and post-marketing surveillance to protect public health.

What is the difference between Pmda vs Pharmacist?

AspectPmdaPharmacist
Required CredentialsTypically requires a specialized certification or training in medical device regulationRequires a pharmacy degree and licensure
Work EnvironmentRegulatory agencies, medical device companies, healthcare complianceCommunity pharmacies, hospitals, healthcare settings
Industry UsageRegulatory and compliance sectors within healthcarePharmaceuticals, 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.

More about Pmda jobs
What cities are hiring for Pmda jobs? Cities with the most Pmda job openings:
What states have the most Pmda jobs? States with the most job openings for Pmda jobs include:
Infographic showing various Pmda job openings in the United States as of May 2026, with employment types broken down into 1% Internship, 98% Full Time, and 1% Contract. Highlights an 76% Physical, 2% Hybrid, and 22% Remote job distribution, with an average salary of $56,921 per year, or $27.4 per hour.
Regulatory Affairs Manager (Transplant Diagnostics)

Regulatory Affairs Manager (Transplant Diagnostics)

Thermo Fisher Scientific

On-site

Full-time

Posted 16 days ago


Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 389 frontline employees who took The Breakroom Quiz

185th of 512 rated manufacturers


Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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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