Regulatory Affairs Specialist

VirtualVocations
Asheville, North Carolina, United States
Full-time

A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio.

Key ResponsibilitiesProvide strategic input on regulatory requirements for new technologies and product modificationsPrepare regulatory submissions, including 510(k) and CE mark documentationMaintain current regulatory knowledge and participate in internal and external auditsRequired Qualifications and EducationBachelor's degree with 2+ years of relevant experience or an advanced degree with no experienceExperience in medical device regulatory affairs is preferredKnowledge of FDA requirements and international regulationsExperience with Class II products (US) and Class I, IIa, and IIb products (EU)Regulatory Affairs Certification (RAC) is a plus

4 days ago
Related jobs
Promoted
VirtualVocations
Asheville, North Carolina

A company is looking for a Senior Regulatory Affairs Specialist responsible for regulatory activities related to medical devices. ...

Promoted
VirtualVocations
Asheville, North Carolina

A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps. ...

Promoted
VirtualVocations
Asheville, North Carolina

A company is looking for a Regulatory Affairs Specialist. ...

Promoted
VirtualVocations
Asheville, North Carolina

A company is looking for a Program Delivery Manager to oversee the delivery of professional certificate and leadership programs. ...

Johnson, Mirmiran & Thompson, Inc.
Asheville, North Carolina

Responsible for delivering all project objectives for assigned projects including; scope, schedule and budget. To help with business development and project management, JMT is looking for a self-motivated individual with working knowledge of the energy market. Establish client and project plans alig...

Sierra Nevada Corporation
Remote NC, NC_NCR
Remote

Do you have an eye for detail and a passion for developing innovation solutions? Join our team! The Sr Supply Chain Compliance Systems Analyst is responsible for overseeing the compliance of SNC's Source-to-Pay (S2P) system areas such as application development, application compliance, systems compl...

Bravura Information Technology Systems, Inc.
Fort Liberty, NC

Degree in IT Management or related; PMP or PgMP; ITIL Intermediate; IAT Level II.Computing Environment Certifications: .Minimum certifications include PMP or PgMP; ITIL Intermediate; and IAT II Certification.Degree in IT Management, or related field.Must demonstrate understanding of Army IT operatio...

Thermo Fisher Scientific
Asheville, North Carolina

Act as a SME supporting product/development team members in order to ensure compliance requirements are being met during the refinement process through release readiness. Support a proactive approach toward investigation and resolving potential product compliance issues. Has effectively lead complia...

UPL
NC, US

Reporting to The State Regulatory Lead, the Specialist is responsible for the professional interaction with the US EPA, state and/or local regulatory authorities, trade associations, grower groups, customers and industrial partners, and competitors as required by job function. The Regulatory Special...

iboss
North Carolina

The IT Governance, Risk, and Compliance Specialist will play a key role on the iboss team by aligning security initiatives with enterprise programs and business objectives. The IT GRC Specialist will make an impact on iboss’ security program and services through experience with various areas includi...