Regulatory Affairs Specialist

Overview


At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees – more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started. If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be. Join us. At QIAGEN, you make a difference every day.



Position Description


The Specialist in Regulatory Affairs is a dynamic individual with combined knowledge of scientific, regulatory and business issues. The challenges include planning and execution of regulatory activities necessary for timely product registration while complying with regulatory requirements and maintaining good contact with regulatory authorities, locally as well as within South East Asia (SEA), interact with Commercial Operations, Regional Regulatory Affairs team and Global Regulatory Affairs.



The key responsibilities of the position are to:



Generate, review, follow-up and maintain global product registration applications, submissions and files update.


Work closely on Regulatory matters from global regulatory members, local authority as well as across other disciplinary Regulatory Agencies in SEA.


Supports regulatory inquiries from Sales & Marketing, R&D and other functional key members.


Keeps track of registration and establishment of licences (renewals, variations, etc).


Generate, review and maintain SOP's relevant for registration of IVD products.


Review of promotion materials


Familiar with the Medical Device Authority of Malaysia and its medical device regulations.


Responsible for ensuring on-going compliance to applicable quality and regulations.



Position Requirements

A Diploma or Degree in a Science-related discipline


Should have at least 3 years of working experience in a similar role or medical device industry


Demonstrated organizational, planning and prioritizing abilities are required


Self-motivated to accomplish performance objectives


Thrive in a fast paced work environment, while possessing the ability to quickly change priorities


Able to perform multiple tasks simultaneously


Demonstrated strong attention to detail


Must be articulate and able to communicate effectively


Ability to work under pressure to meet deadlines


Good verbal and written skills, working knowledge of MS-Word, Excel and/or Access


Flexibility to adjust to changes in schedule, priorities, product availability


Typing and data entry work


Command of the spoken and written English language is required.


Minimal travel required


Job Reference: APAC00352

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