Regulatory Affairs Associate superDimension

Department or Division: Regulatory Affairs
Reports to: VP, Quality & Regulatory Affairs
Summary Statement

Responsible for implementing regulatory strategies for the superDimension product families and for ongoing assessment of approved product iterations.

Position Responsibilities

1. Prepare submissions and technical documentation to worldwide regulatory authorities.

2. Active member of R&D project teams to assure that WW regulatory requirements and standards are incorporated into the product development and design/manufacture of products.

3. Review engineering and manufacturing documents

4. Manage technical files, listing, registrations, certificates and change notifications

5. Assist with Corporate Compliance policies and reporting.

6. Actively involved in external inspections and follow-ups.

7. Serve as internal auditing resource.

Qualifications

1. 5-7 total years experience with medical devices in regulatory affairs role.

2. Strong working knowledge of ISO 13485:2003, EU Medical Device Directive and FDA Quality System Regulation.

3. Experience supporting product development and product commercialization, or manufacturing quality.

4. Strong verbal and written communication, decision making, research, and analytical skills

5. Experience managing multiple tasks concurrently

6. Experience in quality engineering a plus.

7. Strong knowledge and application of statistical techniques and regulatory compliance a plus.

8. Software development/validation/submissions and auditing experience a plus

Education

1. An academic degree in engineering and/or life sciences, or equivalent relevant work experience in Regulatory Affairs.

2. RAC and/or Quality certification preferred.

Location:	Plymouth, MN United States