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Regulatory and Compliance Manager - Medical Device

Location:Morrisville, NC
Benefits:Comprehensive Benefits Package including 401K
Employment Type:Full Time
Description:The Regulatory and Compliance Manager is responsible for pre- and post-market compliance to US and international medical device regulations. Regulatory duties include evaluation of current and changing medical device regulatory policies and implementation of regulations into company policies and procedures.

The position is responsible for strategic regulatory planning for new and revised product introductions into current and existing markets.

The position will develop, document and manage medical device submissions to regulatory authorities for pre-market clearance, especially with regard to the U.S. Food and Drug Administration . The position will support identification and development of verification/validation testing and pre-clinical and clinical study planning as necessary in support of premarket applications. The position will participate and support R&D during the development process in support of pre-market applications. The position will evaluate design changes for regulatory actions and document applicable decisions and actions in accordance with company procedures.

The position will support internal and external audits and inspections as needed.

The position is responsible for support of vigilance reporting.

The position will support development of labeling.

The position will support management of exporting activities.

Project a positive and supportive approach to R&D, sales, marketing, and other related functions to assure compliance in job related areas.
Duties:• Develop and implement policies and procedures for Company compliance and regulatory market clearance to medical device requirements such as ISO 13485, EU’s Medical Device Directive, FDA's IDE and 510(k) regulations, Quality System Regulation 21 CFR Part 820, GLP regulations, and clinical regulations including ISO 14155 and 21 CFR Parts 50, 54, 56, 812, and HIPAA. May include other international regulations as applicable.
• Regulatory strategic planning, pre-market clearance, annual product and facility registrations.
• Evaluate and document regulatory requirements related to verification/validation study inputs and preclinical and clinical study inputs necessary to achieve pre-market clearance. Examples include identification of the requirements necessary for data inclusion in pre-market applications for biocompatibility testing, sterility testing, functional testing, package testing, standards testing, etc.
• Support for import/export programs management, vigilance management and reporting, labeling and promotions compliance.
• Develop training programs and train organization in related regulatory functions including but not limited to complaint handling, AE reporting, field corrections/removals, pre-market processes, labeling and promotions, etc.
• Support regulatory audits.
• Review changes in regulatory landscape and report for management review. Evaluate regulatory changes and identify action plans to assure company compliance to changing regulatory requirements. Assist in the implement plans via procedural changes or other actions as needed. Assist in the communication of regulatory requirements to other departments and employees.
• Support corporate and department objectives especially those related to product market introductions assuring that goals are completed within specified timeframes.
• All Other Essential Duties as directed.
Qualifications:Requires a bachelor's degree in a related technical field, engineering preferred, and at least 10 years of experience in the medical devices field. Familiar with a variety of the field's concepts, practices, procedures and regulations. Regulatory certification required or regulatory related degree required. FDA inspection experience a plus. FDA presentations and negotiations a plus. Medical device regulatory experience required; experience with products containing software, hardware, platform/systems level products, and surgical devices desired.

JOB TRAINING REQUIREMENTS:

Internal operating procedures related to compliance.
General employee training.


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