Company Description

Encore-Medical Inc., a device manufacturer of products used in the structural heart market segment. Our Patent Foramen Ovale (PFO) and Atrial Septal Defect (ASD) occlusive technology is currently being sold outside the United States. Additionally, Encore has just started enrolling patients into its PerFORm trial to obtain FDA approval of its technology for sales in the United States. Encore Medical is in Eagan Minnesota. Encore-Medical Inc. is an exciting young company positioned for rapid growth of its next generation technology.

Regulatory Affairs Specialist (RAS):

Job Summary:

We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join our team. Encore’s RAS is responsible for and manages the completion of the company’s transition of its Class III products from EU MDD to EU MDR. The RAS will help support the company’s FDA-approved PerFOrm clinical trial as need.

Additionally, the RAS will perform technical file remediation as needed; re-registration activities in various global markets as required. The RAS functions as a liaison for the notified body and authorized representatives. The RAS will be involved in activities to organize/execute post market surveillance activities.

Experience:

- 1-2 years of experience in regulatory affairs in the US and OUS medical device industry.

- EU MDR experience preferred

- Experience with clinical trials is desirable

- Project management skills with the ability to prioritize tasks and meet deadlines

- Excellent attention to detail and analytical skills

- Ability to work independently as well as collaboratively in a team environment

Responsibilities:

-Communicate with regulatory agencies regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification and follow-up of submissions under review.

- Manage/assist clinical trial applications and submissions

- Conduct research on regulatory requirements for new global markets and product categories

- Assist on labeling requirements and promotional materials

- Support internal audits and inspections to maintain compliance with regulatory standards

- Assist in the development of quality assurance procedures and processes.

If you are a highly motivated individual with a passion for ensuring regulatory compliance and driving product success, we encourage you to apply. We offer competitive compensation packages, comprehensive benefits, and opportunities for professional growth within our fast-growing organization. Please contact Chris Turnbull at; CTurnbull@Encore-Medical.com

Job Type: Full-time

Pay: $50,000.00 - $75,000.00 per year

Benefits:

• Health insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift

Ability to Relocate:

• Saint Paul, MN 55121: Relocate before starting work (Required)

Work Location: In person