Senior Regulatory Affairs Specialist

Base Pay Range

$/yr - $/yr

Direct message the job poster from PENTAX Medical Americas

Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.

We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.

PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.

In this role, the specialist will work under the guidance of a seasoned manager to ensure PENTAX Medical's products for Endoscopes and Speech, Voice and Swallowing devices, meet global regulatory standards. This role will collaborate across teams, influence strategic decisions and play a crucial role in shaping the future of medical technology.

• 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.
• Review 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.

• Bachelor’s degree in Life Sciences or a related field (Master's preferred).
• Three to 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.

Mid-Senior level

Full-time

Administrative and Quality Assurance

Medical Equipment Manufacturing