***REQUIRED – Please include a cover letter detailing why you are the best candidate for this position.***
Purpose of the Position: Provides leadership, direction and support for the implementation and sustainable initiatives for domestic and international product registrations for BioGX. Serves as the subject matter expert in regulatory & international standards and exercises judgment independently. 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 Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
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
- Some 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
- Self driven
- 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. At least four years of professional experience in regulatory affairs in the area of medical devices.
- FDA 21CFR820: 5 years (Required)
- In-Vitro Diagnostic Directive (IVDD),: 5 years (Required)
- ISO 13485 international: 5 years (Required)
- In-Vitro Diagnostic Regulation (IVDR): 5 years (Required)
- Regulatory Affairs: 5 years (Required)
- Quality Management Systems: 5 years (Required)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.
Job Type: Full-time
Pay: $90,000.00 – $130,000.00 per year
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off