- Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), EU Technical Files, Japanese Todokede/Ninsho Documents, Canadian Device License Applications and other license and registration documents.
- Create and maintain correspondence/files required for foreign export/import regulations
- Provide Regulatory support to cross-functional teams
- Maintain annual facility registration and device listings
- Create and review device labeling and instructions for use
- Interface with FDA Inspectors, ISO Auditors, and OEM Customer Auditors during evaluations and inspections of Microsurgical Technology Quality Systems.
- Contribute to complaint handling process and prepare/submit MDRs and Incidents to appropriate health authorities.
- Participate in Change Board and review and approve Engineering Changes ensuring global change management requirements are being met.
- Provide guidance, training, and direction on regulatory topics to Microsurgical Technology teammates.
- Provide support as needed for non-project related regulatory excellence activities
- Ensure timely, clear communications to internal stakeholders of project status and concerns
- Perform other related duties as assigned
- Knowledge of Domestic and International laws, regulations, and guidance
- Experience in managing regulatory submissions from start to approval
- Excellent communication skills (written and oral) including ability to communicate with International regulatory customers.
- Planning, scheduling and priority setting. Ability to work on multiple projects and adhere to timelines.
- Ability to work cross-functionally, be a self-starter, and work under limited supervision in order to achieve business objectives.
- Working knowledge of FDA QSR, ISO 13485, and EU Medical Device Directive (93/42/EEC), EU Medical Device Regulations (2017/745), MDSAP, and other International regulations. Success with Japanese and Chinese regulatory approvals a plus.
- Proficient in MS Office suite.
- BS/BA in Engineering, Life Sciences, or an equivalent technical field
- 3-5 years of Regulatory experience in a medical device manufacturing environment
- Experience in Ophthalmology or surgical instrument field preferred
- RA/QA certifications a plus
-
Sr. Regulatory Affairs Specialist
2 weeks ago
MicroSurgical Technology Redmond, United StatesCompany Overview · MicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales. · Our products are surgeon-designed and meticu ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Verathon Bothell, United States Full timeOverview · Verathon is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA. This is a site-based role. · The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and submit ...
-
Senior Regulatory Affairs Specialist
5 days ago
Verathon Bothell, United StatesSenior Regulatory Affairs Specialist Location US-Bothell ID Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Hybrid Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, deliver ...
-
Senior Regulatory Affairs Specialist
1 week ago
Verathon Bothell, United States· Senior Regulatory Affairs Specialist · Location · US-Bothell · ID · Category · Quality Assurance/Regulatory Affairs · Position Type · Full-Time · Work Model · Hybrid · Company Overview · Verathon is a global medical device company focused on supporting customers by ...
-
Senior Regulatory Affairs Specialist
3 days ago
Verathon Bothell, United StatesSenior Regulatory Affairs Specialist · Location · US-Bothell · ID · Category · Quality Assurance/Regulatory Affairs · Position Type · Full-Time · Work Model · Hybrid · Company Overview · Verathon · is a global medical device company focused on supporting customers by ...
-
Sr. Regulatory Affairs Specialist
2 days ago
Bruker Seattle, United StatesOverview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming to achieve and maintain regulatory compliance for NanoString's products, with a particular focus on instrument/software development ...
-
Senior Regulatory Affairs Specialist
1 week ago
Hobson Associates Seattle, United StatesJob Title: Senior Regulatory Affairs SpecialistLocation: Greater Seattle Area (Hybrid Role, Three Days In-Office)Our client is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in the Seattle Area.The Senior Regulatory Affair ...
-
Sr. Regulatory Affairs Specialist
3 days ago
Bruker Seattle, United StatesSr. Regulatory Affairs Specialist · Job Locations · US-WA-Seattle | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product d ...
-
Sr. Regulatory Affairs Specialist
1 week ago
Bruker Seattle, United States· Sr. Regulatory Affairs Specialist · Job Locations · US-WA-Seattle | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on produc ...
-
Sr. Regulatory Affairs Specialist
6 days ago
Bruker Nano Inc Seattle, United StatesSr. Regulatory Affairs Specialist Job Locations US-WA-Bothell | US-WA-Seattle ID · of Openings · 1 Job Function Quality & Regulatory Overview The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming ...
-
Regulatory Affairs Specialist III
1 week ago
Bio-Rad Laboratories Seattle, United StatesAs a Regulatory Affairs Specialist, you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Operations RA team, you'll apply your strong leadership skills and knowled ...
-
Regulatory Affairs Specialist III
1 week ago
Bio-Rad Laboratories Seattle, United StatesAs a Bio-Rad Regulatory Affairs Specialist III you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership skills ...
-
Regulatory Affairs Specialist III
4 days ago
AbD Serotec Seattle, United StatesAs a Bio-Rad Regulatory Affairs Specialist III you will supportBio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you`ll apply your strong leadership skills a ...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Verathon Bothell, United StatesVerathon, Inc. · Senior Regulatory Affairs Specialist · Bothell , · Washington · Apply Now · Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, ...
-
Sr. Regulatory Affairs Specialist
3 weeks ago
Bruker Bothell, United StatesSr. Regulatory Affairs Specialist · Job Locations · US-WA-Bothell | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product d ...
-
Sr. Regulatory Affairs Specialist
3 weeks ago
Bruker Bothell, United States· Sr. Regulatory Affairs Specialist · Job Locations · US-WA-Bothell | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product develop ...
-
Sr. Regulatory Affairs Specialist
2 weeks ago
Bruker Bothell, United StatesSr. Regulatory Affairs SpecialistJob LocationsUS-WA-Bothell | US-WA-SeattleID # of Openings1Job FunctionQuality & RegulatoryOverviewThe Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming to achieve ...
-
Senior Regulatory Affairs Specialist
2 hours ago
Fluke Biomedical Corporation Everett, United StatesPosition Summary · The Senior Regulatory Affairs Specialist (Sr, RA Specialist) is responsible for developing regulatory strategies, preparing Local submissions and supporting international submissions to obtain and maintain approval/certification for drug/device products and the ...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Philips International Bothell, United StatesSenior Regulatory Affairs Specialist page is loaded Senior Regulatory Affairs Specialist Apply locations Bothell Colorado Springs Plymouth San Diego Nashville time type Full time posted on Posted 2 Days Ago job requisition id Job Title Senior Regulatory Affairs Specialist Job Des ...
-
Sr. Regulatory Affairs Specialist
1 week ago
SPACE Labs LLC Snoqualmie, United StatesOverview: · At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, i ...
Sr. Regulatory Affairs Specialist - Redmond, United States - MicroSurgical Technology
Description
Company Overview
MicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales.
Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures. Every MST product meets the highest standards and is designed with extraordinary care and attention to all elements of the product, including packaging, look and feel, and ease of adoption into practice. Our product portfolio includes a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery.
Founded in 1976, MSTs passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. And it is our relentless pursuit of addressing our customers needs that creates a profound customer preference. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work
Sr. Regulatory Affairs Specialist
The Sr. Regulatory Affairs Specialist assists with development, management, and implementation of regulatory strategies to support new and existing Class I and Class II ophthalmic medical devices.
Key Responsibilities
Knowledge & Skills
Education & Experience Requirements
Salary range for this position is $90-$125k per year which is the general base range for a successful candidate in the State of Washington. The successful candidates actual pay will be based on various factors such as skills, qualifications and experience.
This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits.
MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law.
Please note that only qualified candidates will be contacted for further consideration.
No Recruiters or Agencies please
