SUMMARY
Supports domestic and international regulatory affairs activities associated with medical device and IVD product lifecycle management, global regulatory compliance, and post-market regulatory activities. Responsibilities include support of domestic and international product registrations, labeling and change assessments, complaint and recall support activities, regulatory remediation efforts, and participation in cross-functional regulatory and quality initiatives. This position will also support selected pre-market regulatory activities including FDA submissions, clinical support activities, and regulatory strategy initiatives as business needs require and offers exposure to multiple aspects of global regulatory affairs across the product lifecycle.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other related duties may be assigned.
• Support domestic and international regulatory compliance activities associated with marketed medical device and IVD products.
• Support product lifecycle management activities including change assessments, labeling updates, regulatory impact assessments, and global registrations.
• Assist with post-market regulatory activities including complaint assessments, recalls, field actions, CAPA support, and regulatory remediation activities.
• Participate in cross-functional activities associated with product quality, compliance, and regulatory risk management.
• Review technical documentation, labeling, promotional materials, and product claims for regulatory compliance.
• Support communication and interaction with regulatory authorities, notified bodies, and external regulatory partners as required.
• Conduct regulatory intelligence searches and monitor changes to domestic and international regulations, guidance documents, and standards.
• Generate and revise quality system procedures, work instructions, and regulatory processes in accordance with current regulatory requirements.
• Participate in regulatory and quality system inspections and audits as needed.
• Support development and execution of regulatory strategies to meet business and product development goals.
• Provide support for selected pre-market regulatory activities including FDA pre-submissions, Special 510(k), Traditional 510(k), De Novo, IDE, and international regulatory submissions as applicable.
• Support Human factors, clinical, and regulatory activities associated with clinical studies and product evaluations as required.
• Coordinate regulatory activities with external consultants and cross-functional internal teams.
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
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.
EDUCATION and/or EXPERIENCE
Bachelor of Science degree (B.S.) in a health, life sciences, engineering, or related discipline from a four-year college or university and 5+ years of regulatory affairs experience within the medical device and/or IVD industry.
Experience supporting post-market regulatory compliance activities including complaint investigations, recalls, field actions, CAPA support, change management, and regulatory remediation activities is strongly preferred.
Exposure to or experience supporting FDA pre-submissions, Special 510(k), Traditional 510(k), De Novo submissions, clinical trial support, IDE submissions, and regulatory strategy development is desirable.
LANGUAGE SKILLS
Strong technical writing and communication skills required. Ability to interpret governmental regulations, technical procedures, and scientific information. Experience with Microsoft Office and electronic document management systems preferred. Mastery of the English language in written form is required.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole
numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
RAC certification preferred but not required. Experience with international regulatory submissions preferred.
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.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Specific job duties that require the physical demands selected are computer activity and review/typing of documents (technical writing).
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.
Hybrid office environment with participation in cross-functional meetings, audits, inspections, and regulatory activities as required.
The noise level in the work environment is usually moderate.
