PENTAX Medical Americas · 1 day ago
Senior Regulatory Affairs Specialist
Montvale, NJ
Full-time
Onsite
Mid, Senior Level
$110K/yr - $120K/yr
3+ years expPENTAX Medical is a leader in the medical device industry focused on improving patient care through innovative endoscopic products. The Senior Regulatory Affairs Specialist will ensure that products meet global regulatory standards, collaborating across teams and influencing strategic decisions in the development of medical technology.
Medical Device
Hiring Manager
Murphy Illenyé, M.S.M.L
Responsibilities
Coordinate with Japan-based Engineering and Regulatory teams to ensure adequate documentation is generated to support regulatory filings in U.S., Canada and LATAM for Pentax branded endoscopes including 510(k) submissions
Represent PENTAX Medical in phone calls and meetings with the U.S. Food and Drug Administration and Health Canada
Participate in cross functional project teams for the development of new and revised Speech, Voice and Swallowing products including creation of Regulatory Assessments and review of design verification, validation protocols and reports and risk management documents and participation in project design review meetings
Work in partnership with manufacturing and QA/QC in designing and enhancing quality management systems to facilitate overall regulatory compliance
Reviews regulatory publications to keep apprised of new regulatory developments
Maintain list of regulatory and quality standards relevant to the design, development and manufacture of Speech, Voice and Swallowing products
Facilitate all FDA registration and listing related activities
Manage interactions with US Customs and Border Control and ensure compatibility and compliance with customs documentation requirements
Support International product registrations
Qualification
Required
Bachelor's degree in Life Sciences or a related field
Three-five years' experience in Regulatory Affairs for a FDA regulated employer
Thorough understanding of domestic and international regulatory requirements for medical devices
Experience with reusable medical devices, including reprocessing processes
Experience with biocompatibility requirements
Proven track record in writing major regulatory device submissions (i.e. 510(k)s), with the ability to successfully manage projects to deadlines
Previous experience in working directly with health authorities is required (i.e. FDA)
Strong ability to manage critical projects as part of an interdisciplinary team
Excellent problem solving and verbal and written communication skills
Must be self-motivated and detailed oriented
Preferred
Masters preferred
Benefits
Comprehensive benefits program
Generous Paid Time Off and Holiday policy
Company
PENTAX Medical Americas
PENTAX Medical is a division of Hoya Group.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Erika Onda
CFO
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