-
Regulatory and Consumer Affairs Administrator
2 weeks ago
State of Vermont Montpelier, United States Full timeOverview The State Of Vermont is looking for a Regulatory & Consumer Affairs Administrator. This position is part of DFR's Banking Licensing Team. This position reviews and coordinates the technical and administrative functions of the Banking Division's licensing program. Analyze ...
-
Manager, Regulatory Affairs CDx
5 days ago
CLS Labcorp Central Laboratory Services Limited Partnership Morrisville, United States Full timeDescription · : Provides regulatory support to CDx and device project teams for the diagnostic, covering all areas from CDx development through approval and launch · Provides regulatory support and input to internal teams involved with IVD/CDx development planning to ensure that ...
-
Manager, Regulatory Affairs CDx
1 week ago
Labcorp Morrisville, United States Full timeAt Labcorp we have a passion in helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great ...
-
Director, Government Relations
38 minutes ago
National Life Group Montpelier, United StatesSummary · Join one of the fastest growing life insurance companies in the country. As part of its growth strategy, National Life Group is expanding its government relations function. The Director, Government Relations will report to the General Counsel and interact with industry ...
-
Director, Government Relations
3 weeks ago
National Life Group Montpelier, United StatesSummary · Join one of the fastest growing life insurance companies in the country. As part of its growth strategy, National Life Group is expanding its government relations function. The Director, Government Relations will report to the General Counsel and interact with industry ...
-
Takeda Pharmaceuticals Montpelier, United StatesTakeda Pharmaceuticals · Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience · Montpelier , · Vermont · Apply Now · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and th ...
-
Director, Government Relations
2 weeks ago
National Life Group Montpelier, United StatesSummary · Join one of the fastest growing life insurance companies in the country. As part of its growth strategy, National Life Group is expanding its government relations function. The Director, Government Relations will report to the General Counsel and interact with industry ...
-
Associate Director, Global Labeling
3 weeks ago
Takeda Pharmaceuticals Montpelier, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Director of Mountain Operations
1 week ago
Jay Peak Resort Montpelier, United StatesFULL-TIME | YEAR ROUND · This is where we're supposed to give you a quick introduction about working at Jay Peak. Except there's nothing quick about what your experiences will be or what our expectations are. In summary, we will expect you to work hard, to help fellow teammates, ...
-
Clinical Affairs Manager
2 weeks ago
Teleflex Morrisville, United StatesPosition Summary The Clinical Affairs Manager provides clinical expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory, Engineering, marketing and other corporate departments on safe and effective use of the Interventional product ...
-
Sr. Director, Procurement
2 weeks ago
Thermo Fisher Scientific Morrisville, United States Full timeJob Description · About Thermo Fisher Scientific: · When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale Join 130,000 colleagues who bring our Mission to life every single day to enable our customers t ...
-
Clinical Affairs Manager
2 weeks ago
Teleflex Morrisville, United StatesPosition Summary The Clinical Affairs Manager provides clinical expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory, Engineering, marketing and other corporate departments on safe and effective use of the Interventional product ...
-
Mgr, Global Tax
2 days ago
The Ladders Morrisville, United States· Manager, Global Tax · Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career ...
-
State & Local Tax Manager
3 weeks ago
Syneos Health Careers Morrisville, United States· State & Local Tax Manager · Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the c ...
-
Assistant Finance Officer
3 weeks ago
Passumpsic Savings Bank Saint Johnsbury, United States Full timePassumpsic Savings Bank is looking for a bright, energetic and highly motivated individual to join our organization as an experienced Assistant Finance Officer at our St Johnsbury Center office. · The right candidate will be responsible for working with and assisting the Chief F ...
-
State & Local Tax Manager
6 days ago
Syneos Health - USA Morrisville, United States Full time· State & Local Tax Manager · Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the c ...
Mgr Regulatory Affairs - East Montpelier, United States - Canon USA & Affiliates
Description
**Mgr Regulatory Affairs - req1193**
**OVERVIEW**
Responsible for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on released products. Participate in trade association activities to ensure that the interests of Canon are represented. Provide input and assist in determining the appropriate regulatory strategies for product clearance.
**RESPONSIBILITIES**
+ Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs.
+ Provide guidance to CMSC Business Unit Managers and Engineering Managers in FDA regulatory submission preparation.
+ Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs.
+ Support legal actions as required by the legal department or directed by the Director, Regulatory Affairs.
+ Provide supervision and training/development of RA staff, as directed by the Director, Regulatory Affairs.
+ Provide training to CMSU and CMSC employees on regulatory items.
+ Regularly audit CMSU's policies and procedures, as directed by the Director, Regulatory Affairs.
+ Track pending FDA submissions (510(k)s, PMAs), IDE, and IRB.
**QUALIFICATIONS**
+ Current knowledge of all laws pertaining to FDA clearance
+ 4 Year / Bachelor's Degree in Regulatory or Engineering sciences
+ 5 years Direct FDA experience, 3 years management experience
+ Min: $107,857 annual equivalency to Max: $151,000 annual equivalency
+ Position is remote; candidate must work in PST
#LI-RS1
#LI-Remote
**_About us_**
_Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family._
