Regulatory Affairs Manager
hace 4 semanas
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 6000 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, international and 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 DescriptionWe are looking for an experienced and motivated Regulatory Affairs (RA) Manager to lead and undertake regulatory responsibility for Mexico and Central Americas (CAR) to ensure our IVD products comply with regional regulations and laws. The CAR RA Manager will report to Sr Director Regulatory Affairs International Program and will partner closely with the RA Manager for Brazil and South America, QIAGEN Franchise RA Directors, Managers, Franchise and Regional Leads to develop and execute effective regulatory strategies to deliver new products to the LATAM region with a responsibility for Mexico and Central America. This role also involves evaluating changes and maintaining existing product licenses.
The CAR RA manager will have direct line management responsibilities for a small team to execute strategy and registrations in accordance with business needs.
Key Responsibilities
- Regulatory Strategy Development : Develop and implement regulatory strategies to facilitate product approvals, registrations, and commercialization for Central Americas. Assess regulatory risks and advise senior management on strategies to achieve regulatory objectives.
- Regulatory Submissions and Compliance : Responsible for the preparation, review, and submission of compliant regulatory documents to Regulatory agencies or Commercial Partners for successful product approvals and licenses. Provides regulatory impact assessments for product/process/supplier changes. Independently makes decisions regarding work and operational plans and schedules to deliver RA functional and business goals for CAR.
- Liaison with Regulatory Agencies : Serve as the primary contact for communication with regulatory agencies for Direct Markets and commercial partners for distributor markets. Represent the company in regulatory meetings and negotiations.
- Cross-Functional Collaboration : Work with teams across the organization, including R&D, quality assurance, manufacturing, marketing, and legal departments. Provide regulatory guidance and support to internal stakeholders. Provides leadership and mentoring to direct reports, including goal setting, prioritization support and professional development and performance management. Assists in the development of best practices for Regulatory Affairs International Program to maintain and establish efficient processes.
- Regulatory Compliance Training and Education : Develop and deliver training programs on regulatory requirements and best practices. Ensure employees are equipped with the knowledge to maintain compliance.
- Regulatory Intelligence and Advocacy : Monitor changes in regulations and industry standards. Conduct regulatory intelligence activities and advocate for the company’s interests.
- Bachelor’s or Master’s degree in a relevant field such as Science, Engineering, Pharmacy, or Life Sciences.
- Minimum 5 years (5+) regulatory affairs experience in a medical device or vitro-diagnostic industry for Mexico and the Central Americas region.
- Demonstrated knowledge and understanding of medical device regulations and delivery or co-ordination of successful medical device license approvals in Mexico, and Central America (Costa Rica, El Salvador, Guatemala, Honduras, Panama, Nicaragua, Belize).
- Fluent in Spanish and Professional Proficiency in English.
- Experience and understanding of regional regulatory requirements for medical devices, IVDs and CDx products. Familiar with processes and interactions with agencies in Central Americas.
- Experience of MD/IVDs/CDx requirements for Mexico and key CAR markets.
Please send your CV in English
What we offerAt 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.
Job Reference: LATAM00139
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