- 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
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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, MST's 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 candidate's 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
