Regulatory Affairs Specialist
1 week ago
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:
- 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
- Command of the spoken and written English language is required.
- Minimal travel required
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
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