Regulatory Affairs Specialist - Seattle, United States - Morair Medtech, LLC

Description

Morair Medtech, LLC is at the forefront of medical technology, specializing in endobronchial treatments for lung diseases. Located in Seattle, we are steered by Robert Barry, a seasoned pioneer with decades of expertise in interventional pulmonology.

Morair has secured funding and trust from a major US-based medical device company, recognizing the game-changing innovation we bring to lung disease treatment.

Position Summary :

The Regulatory Affairs Specialist will work closely with our Senior Director of RA/QA and Executive management team to support clinical studies and future submissions.

The role necessitates proficiency in the development of regulatory submissions for both clinical and market-related aspects. Additionally, this role will help guide our company through the intricate web of regulatory guidelines.


Responsibilities:
Forge and assist in regulatory submissions for US and OUS areas concerning clinical trial propositions.
Shape and support regulatory submissions targeting the US and OUS zones for market placement.
Craft pre-submissions and other submission types.
Administer regulatory files and monitor associated databases.
Reliably relay application updates to our internal teams.
Stellar verbal and written communication proficiencies
Demonstrable proficiency in interpreting and employing standards and regulations.
Sharp analytical abilities for data interpretation.
Prioritizes attention to detail.
Thrives in a dynamic, collaborative, and team-driven setting.


Minimum Education and Experience:

Bachelor's in life science OR a minimum of 5 years' work experience in regulatory affairs supporting medical devices (specific experience in EU MDD/MDR, US FDA class II or class III, etc.).

At least 2 years' hands-on experience supporting regulatory submissions and/or technical files.

Technical Skills – adept with current revisions of:

ISO 13485:
Medical Devices – Quality Management System.

EU MDR 2017/745:
Medical Devices Regulation.
21 CFR Part 820: FDA Quality System Regulation.
21 CFR Part 812: Investigational Device Exemptions

ISO 14971:
Medical Devices - Risk Management Application.

The annual base salary range for this position is from $75,000 to $115,000 and the salary offered will be based on experience and qualifications.

Morair Medtech offers employees a comprehensive benefits package designed to enhance health and well-being. Benefits include medical/vision, dental, paid vacation, paid sick leave, paid holidays, paid parental leave.

We are proud to be an Equal Employment Opportunity (EEO) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected.

We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class.

#J-18808-Ljbffr