Purpose of the Position: Provides support for the implementation and sustainable initiatives of risk management activities for domestic and international products for BioGX. Serves as a subject matter expert in regulatory & international standards for risk management. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Risk Management Specialist will play an indirect role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
Assists with the development of risk management infrastructure necessary to sustain regulatory compliance.
Assists in the authoring of documentation as directed.
Assists with developing, organizing, facilitating, and implementing risk management activities.
Assists with compliance oversight involving PMS, Risk Management, and other areas of focus as assigned.
Informs the Regulatory Affairs Manager on regulatory requirements and changes that affect risk management.
Provides guidance to functional areas where needed in order to continually meet evolving regulatory requirements
Takes all reasonable and prudent measures necessary to assist with regulatory compliance with appropriate notification to, and/or direction from, the Regulatory Affairs Manager.
Assists with ensuring applicable regulatory processes needed for the quality management system are promulgated throughout the organization.
Assists with the development and implementation of strategies to support/maintain certification/registrations.
Keeps abreast of changes to quality regulations, standards, customer requirements and guidance documents. Advise the Regulatory Affairs Manager of any business implications of these changes and lead the activities necessary to address the relevant changes.
Assists with meetings with FDA, Notified Bodies, and other external parties as needed. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities, certifying/notified bodies, customers, and partners.
Provides support to regulatory affairs operations and administrative requirements
Participates in company audits with auditing authorities to ensure processes are monitored, measured, and analyzed to improve or maintain the effectiveness of the QMS. Implements measurable actions necessary to achieve planned results following audits
Adheres to good manufacturing practices and good documentation practices
Some domestic and international travel required
This position may supervise one or more specialists to assist with special areas of compliance.
Qualifications: 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.
Bachelor’s Degree in the sciences preferred
Master’s Degree preferred
1 or more years’ experience in a US FDA-regulated manufacturing environment having direct 510(k) and PMA submission expertise preferred
Strong knowledge of and a minimum of 1 year experience with ISO 14971 and ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems preferred
Excellent written and verbal communication skills
Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
Proficient in typing and keyboard topology
Extremely detail-oriented with strong planning and organizational skills
Able to work without supervision
Education and Experience:
A diploma, certificate or other evidence of formal qualification, awarded on completion of an accredited university degree in law, medicine, engineering or another relevant scientific discipline and/or at least three years of professional experience in regulatory affairs in the area of medical devices.