Regulatory Affairs Specialist (Hybrid)
Who we want
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
We are currently seeking an Regulatory Affairs Associate to join our Medical Division, Hybrid, to be based in Redmond, Washington.
What you will do
As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance. In this role, you will:
- Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
- Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
- Evaluate proposed products for regulatory classification and jurisdiction
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.
- Monitor the progress of the regulatory authority review process through appropriate communications with the agency
- Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
- Maintain current product registrations and assist to process registration changes when required.
- Build relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation.
- Perform other duties as assigned by manager.
What you need
- Bachelor’s degree in an Engineering, Science, or equivalent field
- 0-2 years in a Regulatory Affairs role
- Previous experience with Class II/III medical devices preferred
- Experience authoring regulatory submissions for product approval preferred
- Experience interacting with regulatory agencies preferred
- A passion for compliance and process driven style of working
- Excellent communication skills, ability to influence others and clearly give and receive instructions and direction
- Strong organizational and analytical skills
- Ability to analyze and resolve non-routine regulatory issues using independent judgment
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
- Ability to manage priorities and workflow
- Acute attention to detail
- Proficient on Microsoft Office (Word, Excel, and PowerPoint).
$77,500.00- $120,500.00salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.? Actual minimum and maximum may vary based on location.? Individual pay is based on skills, experience, and other relevant factors.
À propos de l'entreprise
