What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at PENTAX Medical?

Position: Senior Regulatory Affairs Specialist

Location:

Montvale, NJ

Job Id: 20251023RA

# of Openings: 1

About PENTAX Medical

Ourmission 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.

Position Opening:Senior Regulatory Affairs Specialist

Why JOIN Us?

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.

Want More INFO?

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.

Responsibilities of Senior Regulatory Affairs Specialist:

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.

Requirements of Senior Regulatory Affairs Specialist:

Bachelor's degree in Life Sciences or a related field (Masters preferred)
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

It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. PENTAX Medical is an Equal Opportunity Employer, Gender/Minorities/Veterans/Disabled/Sexual Orientation/Gender Identity.

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Senior Regulatory Affairs Specialist

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