BioGX, Inc. is a global molecular diagnostics company that has been focused on the health and safety of communities all over the world from its inception in 2007, originally developing tests for Water Quality, Food Safety and Pharma Quality Control. The company has since grown into a formidable contender in the molecular diagnostics industry, leading the way for simple yet superior molecular diagnostics testing.
The Regulatory Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
This position will be based out of our headquarters in Birmingham, AL.
The Purpose of the Regulatory Affairs Position is to provide leadership, direction and support for the implementation and sustainable initiatives for domestic and international product registrations for BioGX. You will serve as the subject matter expert in regulatory & international standards ensuring effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures .
Essential Duties and Responsibilities:
Directly oversees domestic & international submittals and product registrations prescribed by applicable regulatory agencies
Serve as the Representative who interacts with domestic and international regulatory agencies
Advises the Sr. Director of Regulatory Affairs on regulatory requirements and changes that affect other functional areas
Provide guidance to functional areas where needed in order to continually meet evolving regulatory requirements
Takes all reasonable and prudent measures necessary to maintain regulatory compliance with company and product registration requirements with appropriate notification to, and/or direction from, the Sr. Director, Regulatory Affairs.
Ensure that processes needed for the quality management system are promulgated throughout the organization
Develop and implement strategies to support/maintain certification/registrations
Keeps abreast of changes to quality regulations, standards and guidance documents. Advise management of any business implications of these changes and lead the activities necessary to address the relevant changes
Lead in the identification, development, implementation and continual improvement of quality systems across the organization. Oversee compliance processes and implement improvements
Interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners
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
Domestic and international travel required
Exercises independent judgement and decision making
Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
This position does not require supervisory responsibilities at this time.
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 required; Master’s Degree preferred
Five or more years’ experience in a US FDA-regulated manufacturing environment having direct 510(k) and PMA submission expertise
Strong knowledge of and a minimum of 5 years’ experience with ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
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