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Regulatory Affairs Specialist IV

Job Description:



????????? Responsibilities???????? The incumbent possesses knowledge of regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision.


????????? Domestic and international travel may be required up to 25% of time.


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Essential duties and responsibilities:



????????? Prepare global regulatory submissions such as; 510(k), PMA, for new and modified devices.


????????? Work closely with teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company?s product launch timelines in US market.


????????? Communicate with FDA regarding submissions.


????????? Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.


????????? Review package inserts (labeling) and promotional materials to insure compliance with FDA requirements.



Other job functions:



????????? Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary.


????????? Assist in the development of project specific and departmental budgets.


????????? Represent Company in industry associations, standards organizations, and corporate regulatory/clinical group meetings.


????????? Other duties as assigned.



Requirements:



????????? To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.


????????? The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



Experience & Knowledge


????????? Bachelor?s or Master?s degree in Engineering or life sciences preferred, but other degrees may be considered.


????????? The candidate should have a minimum of 5 years of regulatory submissions experience in the medical device industry specifically with US FDA submissions. Wound, and reconstructive device experience is desired.


????????? Extensive knowledge of FDA regulations required.



Desired skills:



????????? Excellent English written and verbal communication skills including presentation skills, Microsoft Office application skills, self motivated, attention to detail, able to prioritize and manage multiple projects.


????????? Able to lead projects with minimal supervision.



Language skills:



????????? Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents.


????????? Ability to respond to inquiries and complaints from customers and regulatory agencies.


????????? Ability to write detailed technical regulatory submissions, reports and business correspondence.


????????? Ability to effectively present information to other employees, management and regulatory agencies.



Mathematical skills:



????????? Ability to compute ratio, percent and draw and interpret raw data into graphical representations.


????????? Ability to convert English units into metric units and vice versa.


????????? Ability to comprehend and apply principles of algebra, statistics, calculus and mathematical operations used in various engineering and clinical analysis.



Reasoning ability:



????????? Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to define problems, collect data, establish facts and draw valid conclusions.


????????? Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables.



Physical demands:



????????? The physical demands described here are representative of those that must be met by an employee to successfully perform the essentials function of this job.


????????? Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


????????? Requires sitting, talking or listening, more than 2/3 of the time. Walking or standing less than 1/3 of the time. Use of hands to use computer or write documents less than 2/3 of the time.


????????? Ability to travel by air and motor vehicle both domestically and internationally required. Some overnight travel required. Searching for, lifting and carrying records weighing up to 25 pounds less than 1/3 of the time.


????????? Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time.



Work environment:



????????? The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


????????? Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



Requires working most of the time in an office setting.


Job Posting Description Comments



Summary:



????????? Supports in the generation of Technical Files and Design Dossiers


????????? Works with cross functional teams to deliver supporting documentation (IFU, DHF, CER etc.)


????????? Supports and implements the global market change program


????????? Demonstrates strong understanding of MDR requirements


????????? Supports Technical File Audits


????????? Line Management of RA Associate




?Responsibilities:


?


????????? (10%) Assists with preparing and communicates submission/compliance strategy document


????????? (10%) Reports compliance metrics to the RA Franchise lead/Manufacturer Lead and works with the RA Franchise lead/Manufacturer lead to plan and deliver submissions to specified time frames.


????????? (40%) Prepares and reviews technical documentation including labeling and instructions for use and works with relevant team to resolve issues. Post finalized technical documentation to central repository.


????????? (30%) Communicates changes to global markets and provides submission deliverable.


????????? (10%) Prepares for and assists with Notified Body technical audits; responds to any deficiencies




Experience:




????????? Minimum: 3 years Regulatory experience within the Medical Device industry.


????????? Good interpersonal/communication skills are essential.


????????? Experience of providing Regulatory Advice to the business is essential.


????????? Ability to handle multiple demands in a fast-paced environment.


????????? Experience working with large and diverse groups. Strong understanding of EU medical device regulatory affairs preferred.



Competences:



????????? Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills.


?


?Education: Educated to Degree level, or equivalent professional experience



?Licenses/ Certifications: None required, ISO auditing or RACS preferred.


Contact:



Rozina Hudda Email: Click Here to Email Your Resum? - 732-395-4460



Asha Krishna Email: Click Here to Email Your Resum? - 732-395-4591





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