BioLegend is seeking a Regulatory Affairs Associate to support new product development, international registrations and post-market compliance for IVD products. Responsibilities may include participating in new product development teams as well as US, EU, China and other registration and post-market activities.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- US FDA establishment registration and device listing
- Creation and/or maintenance of EU Technical Files
- Preparation of EU IVD Regulation changes
- Assisting with China and other international registrations
- Cross-functional core team member, providing regulatory advice for IVD new product development including appropriate testing
- Review of labeling
- Review of device modifications
- Post-market regulatory activities as applicable
- Review new regulations, standards and guidance for impact
- Other projects or responsibilities as may be required
- innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
- Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
- Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
- Transform – Adapt, learn, re-invent and change for future development and growth
Minimum Qualifications – Education and Experience
- Bachelor’s degree
- Attention to detail
- Highly motivated, dependable and a team player
- Strong organizational, documentation, and communication skills, especially technical writing skills
Preferred Qualifications – Education and Experience
- Bachelor’s degree in life sciences, chemistry, or engineering
- 1-2 years of regulatory affairs or related experience
- Experience in regulatory affairs for IVDs
- US, EU, Canada and/or China regulatory affairs experience
- Knowledge of regulations, guidance and standards
- Experience writing procedures
Diversity is foundational to PerkinElmer and we know that hiring talent with different backgrounds will provide a greater impact for our customers and a more inclusive workplace for our team. Our commitment to creating a culturally diverse workplace is REAL! We know that it’s the people that make PerkinElmer a wonderful, enriching place to work that is why we are always searching for talented and motivated individuals to join the PerkinElmer Family.
So what’s in it for you?
We create a customized development plan to help you achieve your career goals. We partner with you to build a long and rewarding career by providing:
- On-the-job training
- Mentoring relationships
- Ongoing career development planning
- Company and external training programs
- Opportunities for internal career mobility
Our company fosters innovation, knowledge sharing, and teamwork for long-term success. We are committed to the development of your career, giving you opportunities to learn and grow. Simply put, we make a difference for you, so you can make a difference in the world.
We are passionate about our work and the benefits we create for our customers, our communities, and our environment. Every day, we help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
With about 13,000 employees worldwide, we pioneer scientific technologies for food and drug safety, environmental monitoring, industrial analysis, screening and diagnostic testing, and imaging for life sciences. We provide better detection, imaging, and informatics to help our customers make a profound impact on the world.