Regulatory Specialist III

Work Schedule

Environmental Conditions

Job Description

When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have a real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

• Develop and implement regulatory strategy across projects to ensure that company products are safe, legal, and meet expectations with regulations.
• Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies.
• Prepare documents for regulatory filing and agency consultation materials under the PMD Act.
• Lead not only submission activities but also PMDA consultation
• Maintain regulatory documents to keep registration status.
• Represent the Regulatory Affairs function at multi-departmental project meetings
• Liaise with competent authorities and notified bodies to seek advice and guidance.

How will you get here?

Education and experience

• Bachelor’s degree or above in chemical, pharmaceutical, medical, science, etc.
• 3-6 years of Regulatory experience in the IVD or medical device industry. IVD industry preferred.
• Experience with Molecular Biology products (PCR, Sequencing) a plus

Knowledge, Skills, Abilities

• Ability to plan multiple tasks and effectively prioritize activities
• Effective communicator with internal and external contacts
• Proactive with Proven ability to work under own initiative, and strong team player
• Fluent in Japanese. Business level in English (oral and written) a plus
• Experience with Microsoft Office applications (outlook, excel, powerpoint, word)
• Pharmacist license holder preferred but not required

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

We offer a competitive salary, an annual incentive bonus plan, a 401K with a company match of up, tuition reimbursement, and a range of other employee benefits!

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.