Regulatory Affairs Associate

6 months ago

Concord, Canada SCIEX Full time

For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs Associate is responsible for supporting cross-functional teams in achieving and maintaining compliance to applicable regulatory requirements for marketed products to ensure continued success in established markets. As part of this role, you will have the opportunity to work with an international team and gain working knowledge of international regulatory bodies and requirements.

This position is part of the Regulatory Affairs team and will be HYBRID, located in Concord, ON. Join us in making our regulatory knowledge a competitive advantage in the medical device industry.

**In this role, you will have the opportunity to**:

- Review and approve product claims used within marketing and promotional material
- Review product changes, ensuring that the regulatory filings for marketed products are kept up to date as appropriate
- Monitor the regulatory environment for new and updated requirements related to in vitro diagnostic devices, and communicate key learnings to affected stakeholders as appropriate

**The essential requirements of the job include**:

- Minimum Bachelor’s degree in a scientific field (e.g., Life Science, Chemistry, etc.) with 1 year of working experience
- Alternatively, Regulatory Affairs Graduate Certificate
- Direct experience with periodic reviews of applicable standards, guidance documents, and regulations, and updating procedures as required.

**It would be a plus if you also possess previous experience in**:

- The European Union In Vitro Diagnostic Regulations and associated Medical Device Coordination Group documents.
- Software in a Medical Device (SiMD)

At SCIEX we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for SCIEX can provide.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

LI-LC

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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