The Purpose of the Regulatory Affairs Specialist is to provide support for the implementation and sustainable initiatives for domestic and international product registrations for BioGX. Serves as a subject matter expert in regulatory & international standards. 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 Regulatory Affairs 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 domestic & international submittals and product registrations prescribed by applicable regulatory agencies
- Informs the Regulatory Affairs Manager on regulatory requirements and changes that affect other functional areas
- 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 and product registration requirements with appropriate notification to, and/or direction from, the Regulatory Affairs Manager.
- Assists with ensuring that 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 and guidance documents. Advise management 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 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
- Some domestic and international travel required
- 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
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
- Three 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 3 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
- Self driven
- Able to work without supervision
Education and Experience:
- Bachelor’s Degree required ;Master’s Degree preferred
Pay: Starting From $55,000.00 per year
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off