Regulatory Affairs Specialist
| Company | Zeiss |
|---|---|
| Location | Toronto, ON, Canada |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Description
About Us:
How many companies can say they’ve been in business for over 177 years?!
Here at ZEISS, we certainlycan! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone!Make a difference, come join the team!
Location/Region: This position is located in Toronto area.
What’s the role?
As a Regulatory Affairs Specialist, you get to work with an astonishing team that plays a vital role in Carl Zeiss Limited and Vision..Show case your skills and experience with process enhancement.
Sound Interesting?
Here’s what you’ll do:
- Establish and implement Standard Operating Procedures (SOPs) for GMP requirements
- Perform internal audits to ensure compliance with regulatory standards and internal policies
- Prepare and submit regulatory licensing applications to Health Canada for new and amended applications of Class II, III, and IV medical devices
- Renew the Manufacturer’s License and Medical Device Establishment License (MDEL)
- Submit recall and mandatory reports to Health Canada as required and evaluate change proposals to recommend regulatory action items
- Manage conformity testing and ensure all testing meets regulatory standar
- Prepare documentation and support materials for Health Canada audits related to Drug Establishment License (DEL) applications and oversee the release compliance process.
- Work closely with our QA Staff to support maintenance of our ISO 9001 Quality Management System (QMS)
- Other duties as required
Do you qualify?
- Minimum of 5 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry or equivalent
- Post Secondary education in Regulatory Affairs or Applied Sciences or equivalent.
- Proven experience in GMP and maintaining detailed records in a manufacturing environment
- Strong background in Drug conformity testing and related regulatory requirements is an asset
- Extensive experience with Health Canada medical device and drug regulatory submissions
- Familiarity with Drug Establishment License (DEL) applications and audit processes
- Familiarity with regulatory documentation formats such as STED and IMDRF
- Certification related to GMP and drug quality management system auditing is a bonus
- QA management experience would be an asset
- Must have excellent verbal and written communication skills in English
- Excellent presentation skills
- Must be highly organized, be able to prioritize and manage time effectively
- Working knowledge in MS Office applications Word, Excel, Powerpoint, etc.
- Solid interpersonal skills – to be able to work closely with other departments
- A relevant post secondary diploma or degree would be beneficial
ZEISS is an equal opportunity employer.
Your ZEISS Recruiting Team:
Jo Anne Mittelman
COVID-19 Considerations
At ZEISS our highest priority is the safety of our employees and Customers. As a result, we are adopting additional prevention measures to ensure the safety of our employees and Customers. Therefore, any offer of employment is conditional upon you submitting proof that you have been fully vaccinated with a Health Canada or World Health Organization (WHO) approved COVID-19 vaccination as soon as possible and no later than fourteen (14) calendar days prior to the effective start date, in addition to satisfying any other condition(s) that may be set out in an offer. If a candidate fails to satisfy this condition (or any other condition(s) set out in an offer), any offer of employment shall be immediately rescinded.
Accommodation
ZEISS is committed to creating an accessible and inclusive organization. We are committed to providing barrier-free and accessible employment practices. Should you require Code-protected accommodation through any stage of the recruitment process, please make them known when contacted and we will work with you to meet your needs.
Benefits
Not Specified