Oversees the pre-market regulation process for products requiring governmental or ELITechGroup action before they can be placed on the market, including filing necessary applications and handling all government interactions, in particular, but not limited to, US FDA. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
Essential Duties and Responsibilities
Implements and maintains regulatory records.
Defines project/product regulatory strategy.
Develops content for Pre-submissions, Pre-IDEs, 510(k)s and PMAs to enable seamless product entry into the market.
Works with other project team member to develop the definition of the data required for each submission.
Writes submissions documents clearly, completely and consistent with regulatory requirements.
Assembles submissions packages and affects submission to regulatory authorities.
Tracks and facilitates the progress of submissions through the review process.
Coordinates additional information inquiries during the governmental review process and provides the additional information to the governmental body.
Ensures that proper notifications are made to relevant governmental authorities for products within the scope of responsibility.
Responsible to make the determination whether new testing or governmental action is necessary before any proposed process or products change may be implemented and document the rationale.
Monitors FDA regulatory field actions and clearances/approvals and notifies the business of relevant actions for products within the scope of responsibility.
Coordinates the evaluation of potential MDRs and makes the MDR, if required.
Supports all ELITechGroup businesses by responding to requests for regulatory assistance within knowledge- base.
Develops and maintains procedures for Regulatory Operations
Maintains current knowledge and awareness of relevant and changing regulatory requirements.
Develops and performs organizational training in the area of regulation.
Easily and readily interacts with governmental regulatory personnel.
Participates in internal quality audits as well as suppler and contractor audits, as scheduled.
To perform the job successfully, an individual should demonstrate the following competencies:
Communication superior English-language communication in normal written, specialized written and oral format to a variety of audiences, including highly technical personnel and regulators; represents the company with external parties in collaborative and negotiated relationships.
Initiative works independently with little or no supervision; takes independent actions and calculated risks; asks for and offers help when needed. Develops records systems in compliance with regulatory requirements.
Leadership exhibits high ethical values and excellent leadership skills, along with a demonstrated ability to organize and direct major work activities and administrative operations; shows an ability to plan, organize and manage a large, complex and highly skilled department; possesses strong analytical, organizational, inter-personal and management skills. Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values.
Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; develops realistic action plans.
Problem Solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics.
Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration; follows through on commitments.
Project Management - coordinates projects; communicates changes and progress; completes projects on time and budget.
Quality Models superior accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Reasoning Ability - ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Teamwork - balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit.
Bachelor's degree with a minimum of 7 years' experience in IVDs.
Applied experience with 510(k) submissions.
ISO regulated environment or equivalent training.
Knowledge of ISO 13485, ISO 14971, FDA regulations and IVDD.
Experience with PMA submissions. Experience with Microbiology or Molecular Diagnostics submissions.
While performing the duties of this job, the employee is not exposed to environmental conditions. The noise level in the work environment is usually moderate.
Additional Salary Information: Benefits Include Medical, Dental, Vision, 401k, Life Insurance, Long Term Disability and PTO
Internal Number: 767598
The ELITech Group enables better medical decisions by delivering high-value diagnostic solutions to laboratories operating closer to the patient. Our mission is to improve patient care by developing market-leading diagnostic products that enable physicians to more rapidly and accurately determine the course of treatment. ELITech is committed to serve laboratories to a level not delivered today with superior support customers can count on.