Regulatory Affairs Specialist

The specialist will be part of the International Regulatory affairs group and will work with in country reps on document submissions for product development.

Responsibilities:

Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements participate in developing regulatory strategy prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g. OUS the globe minus US EU Canada).
Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues and/or reporting to management.
Other incidental duties assigned by Leadership.

Skills:

Bachelors Degree in scientific field required
Minimum 2 years of experience as a Regulatory Affairs professional
Ignite experience a plus
Microsoft Office experience required
Good written and verbal communication skills and interpersonal relationship skills
Good problemsolving organizational analytical and critical thinking skills
knowledge of global regulations relevant to medical devices Class II and/or Class III devices
knowledge and understanding of global regulatory requirements for new products or product changes required

MondayFriday ONSITE in Irvine
8AM to 5PM
Pay: 4650/hr

**Unable to sponsor any visas at this time**
**No C2C**