Regulatory Affairs Specialist – Gorbel, Inc. – Fishers, NY (Rochester Area)

Position Summary:
Responsible for the development, implementation and administration of organization activities, policies and procedures to support and ensure regulatory compliance. Act as core team member supporting product development and manufacturing engineers with guidance to maintain compliance with US and appropriate international regulatory requirements. Uses a thorough understanding of regulatory post-market obligations for the US FDA and international post-market regulatory requirements to direct activities that ensure compliance.

Essential Duties and Responsibilities:

  • Understands and interprets U.S. and international medical device regulatory requirements, provides interpretive guidance on requirements to product development, production, service and installation teams.
  • Provides regulatory risk assessments and options to appropriate teams and management.
  • Manages regulatory compliance, evaluates regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to management and functional business departments.
  • Interact effectively with functional business departments in order to coordinate and facilitate documentation required for submissions and design files, ensuring that timelines are met and files are comprehensive.
  • Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products.
  • Oversees the product development team activities relating to design and development processes to ensure regulatory compliance.
  • Responsible for the day-to-day oversight and management of assigned projects. Serves as the primary regulatory resource for change to and prioritization of projects.
  • Compile and maintain appropriate Quality Management System files.
  • Provide leadership and direction to assigned resources. Provide timely and appropriate performance feedback.
  • Responsible maintaining FDA Class I exempt Registration and Listing.
  • Act as direct liaison with FDA as needed, including escorting government inspectors during inspections and providing post-inspection follow-up information as requested.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Serves as primary Gorbel Medical interface with regulatory agencies. Other duties as assigned.

Qualifications:

  • Possess a minimum 5 years medical device regulatory affairs experience and/or training or equivalent combination of education and experience.
  • Experience in effective interaction with manufacturing, quality, clinical/medical and marketing departments.
  • FDA Class I and Class II regulatory experience, (21 CFR, Part 820).
  • A working knowledge of FDA and regulations and how to interpret and monitor updates with experience or knowledge in US Title 21 CFR, Part 820.
  • Thorough understanding of Class I Design Controls
  • Experience with international regulations, particularly ISO 13485.
  • Demonstrated experience in project management and FDA medical device documentation.
  • Demonstrated ability to work effectively in a highly charged, fluid environment.
  • Demonstrated ability to independently manage multiple projects.
  • Post-market medical device experience.
  • Very detail-oriented, well-organized and driven to meet deadlines and program goals.
  • Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
  • Good computer skills with proficiency in Microsoft Office.
  • Some domestic and international travel required (10-15%)
  • Ability to compile data and summarize results.
  • Bachelor’s degree

Job Type: Full-time

Required experience:

  • At least five years of experience: 5 years

Required education:

  • Bachelor’s

http://www.indeed.com/cmp/Gorbel,-Inc./jobs/Regulatory-Affair-Specialist-f8ccc1e4b7af7009?q=Gorbel