Company summary: A global Fortune 500 is looking to add a new member to their growing Regulatory team. They're working on a large variety of device products, and this individual will have the opportunity to work with various health authorities to ensure this innovative pipeline meets regulatory requirements.
Though this is a large global corporation, the regulatory team itself is very collaborative and you will work closely with your director and other teams, bringing a cross-functional aspect to your work. Additionally, there are many benefits to keep employees happy across all functions!
RESPONSIBILITIES:
In this role you will be responsible for:
- Generation and management of product submissions
- Collaboration with relevant heath authorities
- Managing regulatory compliance activities
- Regulatory assessments
- Other relevant regulatory/compliance duties
REQUIREMENTS:
The client requires that all candidates have:
- BS or higher in relevant field (MS or RAC preferred)
- 5+ years of industry experience (device or pharmaceuticals)
- An understanding of medical device regulations
- Experience with the FDA/EU/Health Canada regulations
- Strong communication skills
