Share this Job

Regulatory Affairs Specialist

Date: Jan 2, 2019

Location: Singapore, SG

Company: Terumo BCT, Inc.

Country:  Singapore 

 

 

JOB TITLE:  Regulatory Affairs Specialist

 

JOB SUMMARY

Working with direction, assists in fulfilling South East Asia Regulatory requirements by applying a basic understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals, or biologics.

 

ESSENTIAL DUTIES

  • Using a broad base of knowledge and understanding of regulatory requirements, assumes responsibility for one or more regulatory affairs areas
  • Identifies and defines contents for Regulatory filings/dossiers.  Assist the assembly and creation of these documents for their timely submission to Regulatory authorities.
  • Maintenance of sometimes complex existing licenses/certificates, product approvals and post market notifications
  • Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines.  May collaborate with individuals at different levels in solving problems that are routine in nature
  • Interprets, executes, and recommends modifications to operating policies where appropriate
  • Helps to manage & maintain regulatory information systems

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

Up to 2 years of experience in Regulatory Affairs but fresh graduates with no experience are welcome to apply.

 

Skills

  • Basic knowledge of South East Asian medical device and/or pharmaceuticals and/or biologics regulations and standards
  • A working knowledge of medical devices design and principles
  • Ability to prepare regulatory documentation in compliance with regional regulatory requirements
  • Ability to author sections of a regulatory submission under supervision, with content review at end
  • Keen and able learner
  • Recognize and awareness of gaps and potentially suggest solutions
  • Able to identify  adequacy of sections and overall content of submissions
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and and in writing
  • Demonstrated analytical and creative thinking skills and the ability to solve complex problems

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

 

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

 

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

 

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Job Segment: Medical, R&D, Engineer, Information Systems, Medical Device, Healthcare, Research, Engineering, Technology