Sr Specialist Regulatory Affairs

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

**This person will be a key **contributor** to our Regulatory Affairs organization in Brazil, being responsible for coordinate information on several projects simultaneously in the area and will ensure the quality of products, tools, and services developed by QIAGEN. **Our corporate activities are growing and we are currently seeking for full-time experienced Regulatory Affairs Specialist.**

More specifically, you will:

- Coordinate and ensure registration pipeline/changes and renewals program submission is done in timely manner
- Participate in teams to establish and execute regulatory strategic plans with mínimal guidance.
- Prepare and submit proper regulatory documents and technical files to MoH with mínimal supervision.
- Provide assistance with establishment registration licenses.
- Contribute to introduce new /modified products/ extension line & others.
- Manage and track regulatory projects/requests to ensure alignment with business goals and timely responses
- Prepare alert communications according to registration process progress and findings during this.
- Coordinate information on several projects simultaneously.
- Supports regional team on product submissions schedules, prioritization and pipeline management.
- Interacts with other QIAGEN stakeholders, government agencies in a professional, decisive, & articulate manner.
- Act as liaison for assigned franchises to support business plans and regulatory needs.
- Request and follow-up documentation from Data Center to prepare registration dossiers
- Review and analyze market licenses and labeling
- Ensure that Regulatory and Labeling Databases are well updated as per approvals received
- May identify and communicate new regulatory/legal requirements.
- Support Commercial, bids and functional areas consultations to clarify regulatory questions
- Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies.
- Adhere to company and regulatory bodies’ policies and procedures regarding product introductions, changes and labeling.
- Support to review promotional materials according to current product registration and MOH regulation.

Position Requirements
- Must have 3-4 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for IVD product or Medical Devices experience
- Desirable experience in Medical Devices or Pharma background.
- A Bachelor’s Degree in Biology, Biomedice, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience.
- Advanced Skills in English is preferred. Fluent in Portuguese.

Personal Requirements
- Team work
- Communication
- Flexibility

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.

We offer:

- Possibility to develop in an international company
- Attractive office location
- Attractive benefits package
- Medical Insurance
- Dental Insurance
- Life Insurance
- Gympass

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.