Regulatory Affairs Specialist

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Job title: RA Specialist

When you’re part of the team, you’ll do important work, like helping customers in finding cures, protecting the environment or making sure our food is safe. Your work will have 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 PMD Act.
• Maintain regulatory documents to keep registration status.
• Manage clinical validation studies with clinical affairs
• Represent the Regulatory Affairs function at multi-departmental 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 for chemical, pharmaceutical, medical, science, etc.
• Regulatory experience in the IVD or medical device industry

Knowledge, Skills, Abilities

• Ability to plan multiple tasks and effectively prioritize activities
• Effective communicator with internal customers
• Proactive with proven ability to work under own initiative, and strong team player
• Fluent in Japanese and business level in English (oral and written)
• Excellent IT skills
• Pharmacist license holder preferred

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.

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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

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

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.