grow with nexxt spine

Nexxt Spine LLC, one of the best positioned companies in the medical device industry is searching for a Regulatory Affairs Specialist to add to our dynamic team.  Located in Noblesville, IN, Nexxt Spine LLC has won awards for designing, manufacturing, distributing, and marketing a rapidly expanding line of spinal implants and instruments.

JOB DESCRIPTION

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.  Manage ISO certification process and international approvals.

ESSENTIAL DUTIES AND RESPONSIBLIITIES

• Compile and maintain regulatory documentation databases or systems.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Analyze product complaints and make recommendations regarding their reportability.
• Develop or conduct employee regulatory training.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

QUALIFICATIONS 

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Must be a critical thinker, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to new opportunities.
• Expertise in FDA, GMP & ISO requirements. 
• Must be self motivated and be able to build consensus on projects.

EXPERIENCE        

5+ years relevant experience in Regulatory affairs.

  
Send resume via email to AKoors@NexxtSpine.com or fax to 317-245-2518.

Nexxt Spine LLC is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.