Regulatory Affairs, Quality & Compliance-ClorDiSys-On-site NJ

Company Background

ClorDiSys Solutions, a wholly owned subsidiary of Allentown LLC, develops, manufactures, and markets a complete, gaseous chlorine dioxide-based portfolio of high-quality sterilizers for medical devices.

ClorDiSys also operates an FDA approved contract sterilization in Branchburg, NJ. ClorDiSys’ technology is gaining traction as an alternative to Ethylene Oxide given it has several advantages from an environmental and human-safety perspective.

We believe that gaseous chlorine dioxide represents the future of medical device sterilization, and our mission is to generate lasting change and produce greater outcomes for our customers and the world.

At ClorDiSys we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by helping us create a legacy you can take throughout your career.

We want you to be bold, think outside the box, experiment, innovate and deliver the next generation of medical device sterilant.

You will be part of a collaborative, respectful and resilient team of associates and leaders, working together as partners to achieve more than you thought possible, providing real-world change by eliminating a known carcinogen and saving people’s lives.

In other words, another day of work at ClorDiSys!

Come join us and help improve the world!

Job Summary

We are looking to hire an exceptional regulatory affairs, quality & compliance leader to help us realize our goals through the education of both customers and regulatory agencies, such as the FDA and EU Notified Bodies, regarding our differentiated technology.

We are looking for a person with the energy and the experience to drive industry change on a world-wide basis. The ideal candidate will also have relationships with the key regulatory bodies and will spearhead the move of our novel gaseous chlorine dioxide technology toward mainstream acceptance.

This individual will lead the formulation and execution of the company’s regulatory strategy as well as prepare documents and / or submissions required to obtain clearance or approval from government agencies for commercial sterilization of products utilizing gaseous chlorine dioxide worldwide.

This position will also have the chance to interact with ClorDiSys’ existing and prospective customers as they navigate the testing and validation processes.

In order to be successful in this role, this individual must be able to function at a high level both independently as a decision-maker on regulatory issues, as well as cross functionally as part of a growing organization.

The job location is based in Branchburg, NJ and requires an on-site presence.

Job Details / Responsibilities

Business Development, Regulatory & Quality

• Foster relationships with key regulatory bodies (FDA, EPA, OSHA, etc.) and standards committees (AAMI, etc.) and oversee regulatory audits at CDS’ facility
• Define strategy for, and lead, initiative to move ClorDiSys’ chlorine dioxide technology from Novel to Established Method classification with the FDA
• Develop ISO standard for ClorDiSys’ technology and sterilization process
• Maintain / improve upon internal quality & compliance documents, systems & processes
• Determine appropriate regulatory requirements and strategies for new product development projects regarding chlorine dioxide sterilization including both domestic and foreign activities while providing regulatory consultation to other internal and external stakeholders
• Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
• Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed as well as properly interpret and apply regulatory requirements to ensure submission approvals
• Maintain up to date knowledge of Federal USA, Canadian, MDR and other international regulations, policies and guidance pertaining to medical device sterilization and monitor impact on submission strategies
• Oversee processes involved with maintaining annual licenses, registrations and device listings
• Pursue government grants and environmental accreditations (EcoVadis, etc.)
• Assist with the development and publishing of peer-reviewed articles to highlight our technology and equivalence / differentiators vs.

other sterilization modalities

Assist with developing the layout of new sterilization facility and subsequent implementation of process flows to ensure ongoing quality and compliance

Business Development / Validation :

• Assist customers by providing regulatory input / guidance and supplying materials for US and International product registrations as well as certification of appropriate US commercialization statuses
• Plan, organize and coordinate customer validation activities at the ClorDiSys site as well as write validation protocols and final reports
• Review and approve customer or consultant supplied validation or test protocols for execution within the limitation of the facility’s equipment, operating procedures and compliance with current regulatory standards
• Respond to customers’ inquiries to ensure prompt and accurate communication related to technical and validation issues
• Ensure validation activities are carried out according to the agreed time-schedule and communicate follow up to relevant persons
• Act as subject matter expert for audits in regard to validation activities (interaction with customer / internal / regulatory body auditors)
• Oversee the execution of validation protocols and technically-driven customer projects relevant responsibilities include, but are not limited to : Scheduling sterilization runs, lab testing, sample handling and microbiological samplesAssuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratoryLeading cycle programming and preparation of necessary process documents and safety assessmentsProviding support to the engineering team for IQ / OQ / PQ activitiesMaintaining the quality and integrity of information required for validation recordsAssisting with corrective action and validation process improvement activities and updating facility stakeholders and customers regarding validation related deficienciesPerforming other duties as required to support overall operations

Knowledge, Skills and Abilities

• Knowledge of FDA, EU, TGA and other International requirements as well as an understanding of regulatory agency structure, processes and key personnel
• Knowledge of GLP / GMP requirements
• Knowledge of medical device product labeling requirements and standards
• Ability to make correct decisions based on interpretations of applicable regulator requirements across the medical device industry
• Ability to analyze data and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution
• Advanced ability for both independent work and teamwork
• Strong organizational and time management skills with ability to meet deadlines
• Strong written and oral communication skills as well as computer skills (MS Office, Adobe Acrobat, etc.)

Qualifications / Background Experiences

• Bachelor’s degree in science (biology, microbiology, chemistry), engineering or other relevant focus area; Master’s degree or PhD preferred
• 10 15 years of experience in an FDA regulated industry including experience writing 510k or PMA submissions in the last 5 years
• Experience in a medical device regulatory / quality assurance environment preferred
• Experience with the sterilization aspects of 510(k) / IDE / PMA device submissions and / or other worldwide submissions and clearances preferred
• Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 11135, ISO 14937, ISO 13485, and other global regulatory requirements and quality standards preferred
• Certifications are a plus (such as RAC from the Regulatory Affairs Professionals Society)
• Supervisory or management experience preferred
29 days ago