Regulatory Affairs Specialist - Principal

Regulatory Affairs Specialist, Principal
POSITION REPORTS TO: Designated Manager or Supervisor
POSITION DIRECTLY SUPERVISES: No one
JOB DIVISION: Business Operations
OVER-TIME STATUS: Exempt

PURPOSE OF POSITION: Responsible for leading RA/QA team in facilitating continuous quality improvements and ensuring regulatory compliance. Leads projects and implements regulatory strategies to ensure quality system management.

TO FULFILL THIS POSITION SUCCESSFULLY, AN INDIVIDUAL MUST BE ABLE TO PERFORM EACH ESSENTIAL FUNCTION SATISFACTORILY.
Essential Functions:
§ Prepares documentation and submits regulatory filings including 510k submissions, Device Master files, technical files, and post market surveillance.
§ Maintains company registrations and device listings in the US, Canada, EU, Brazil, Japan, and other international markets.
§ Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
§ Coordinates with international regulatory team members on product changes and regulatory notifications and approval requirements.
§ Provides proactive knowledge and expertise as a representative of Regulatory Affairs on project teams.
§ Interpret regulations and regulatory procedures.
§ Provides leadership in developing and implementing regulatory strategies and processes.
§ Analyzes advertising, labeling, and public communications for regulatory compliance.
§ Ensures compliance with design control regulations during product development and delivery activities.
§ Reports any significant regulatory issues related to a product's release.
§ Maintains up-to-date knowledge on international and domestic regulatory requirements.
§ Evaluates compliance with applicable regulations, project policies, and procedures.
§ Participates and assists with FDA facility inspections, Notified Body Audits, and other governmental inspections as directed.
§ Establishes, tracks, and manages regulatory project timelines, status updates, and documentation.
§ Represents Regulatory Affairs functional area in the review and approval of all Engineering Change Orders (ECO).
§ Provides regulatory guidance with regards to the preparation, review, and approval of labeling and promotional materials.
§ Provides regulatory assistance and review in clinical operations activities including review of essential documents, adverse event reporting, etc.
§ Performs regulatory research and stay abreast of changes in the agency regulations and requirements.
§ Provides regulatory support for regulatory compliance activities as required.
§ Maintains well-organized, auditable regulatory files.
§ Analyze existing systems and procedures, recommends solutions/improvements, and write work instructions and standard operating procedures as needed to support departmental functions and Quality System.
§ Maintains claims log for medical devices.
§ Reviews and writes standard operating procedures and other RA/QA policies
§ Works with technical staff to foster understanding of SOPs and guidance documentation.
§ Serves as backup for all other regulatory projects and lends guidance to more junior level regulatory personnel.
§ Performs other related duties and projects as business needs require at direction of management.

The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.

MINIMUM QUALIFICATIONS: THE REQUIREMENTS LISTED BELOW ARE REPRESENTATIVE OF THE KNOWLEDGE, SKILL, AND ABILITY NECESSARY TO SUCCESSFULLY PERFORM THE ESSENTIAL FUNCTIONS OF THE POSITION.
Education and Experience:
§ Bachelor's degree in related field preferred.
§ Minimum seven (7) years of experience in Regulatory Affairs.
§ Knowledge of RA regulations and guidance such as Good Mfg Practice (GMP)
§ Knowledge of and experience with FDA 510k and ISO 13485 Standards
§ Knowledge of FDA/ISO audits and inspections.

Special Requirements/Certification:
§ Regulatory Affairs Certification required.
Communication Skills:
§ Must possess proficient English skills, both written and verbal.
§ Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel in a professional and effective manner.
§ Proven ability to develop strong relationships across multiple functions.
§ Demonstrated written skills to convey high-level concepts in concise written form.
§ Ability to effectively present information and respond to questions from management and general stakeholders in initiatives.
§ Ability to write reports, business correspondence, and procedure manuals.
§ Ability to create and compose written materials with proper English grammar and punctuation.
§ Ability to communicate clearly with employees, management, and team members.
§ Ability to convey information in a clear and concise manner.
§ Ability to provide constructive feedback in a professional and non-threatening manner.
§ Ability to communicate effectively in a multi-cultural business environment.

Knowledge and Abilities:
§ Proficient knowledge of general office procedures.
§ Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
§ Proficient quantitative and analytical skills.
§ Demonstrated prioritization and time management skills.
§ Demonstrated negotiation abilities.
§ Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
§ Demonstrated high standard of quality of work.
§ Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
§ Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
§ Demonstrated reliability, dependability, and flexibility in work habits.
§ Must be detail-oriented with well-developed organizational and analytical skills.
§ Ability to analyze and collate data for presentations and reports.
§ Ability to prioritize and organize project tasks and goals effectively.
§ Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
§ Ability to research new and emerging technologies and practices.
§ Ability to read technical diagrams, graphs, and instructions.
§ Ability to interpret and collate data to present an accurate picture of market potential.
§ Ability to research new and emerging technologies and practices.
§ Ability to read technical diagrams, graphs, and instructions.

PHYSICAL DEMANDS: THE PHYSICAL DEMANDS LISTED BELOW ARE REPRESENTATIVE OF THOSE THAT MUST BE MET BY AN EMPLOYEE TO SUCCESSFULLY PERFORM THE ESSENTIAL FUNCTIONS OF THIS POSITION.
§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
§ Ability to frequently communicate with others.
§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
§ Ability to seldom stand and/or walk for extended periods of time.
§ Ability to seldom climb stairs at some locations.
§ Ability to seldom push and/or pull up to five (5) pounds.
§ Ability to frequently lift or carry up to five (5) pounds.
§ Ability to keyboard for extended periods of time.
§ Ability to function in an environment with frequent interruptions.
§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
§ Ability to frequently travel to locations away from primary workplace as necessary.

WORK ENVIRONMENT: THE WORK ENVIRONMENT CHARACTERISTICS DESCRIBED HERE ARE REPRESENTATIVE OF THOSE AN EMPLOYEE ENCOUNTERS WHILE PERFORMING THE ESSENTIAL FUNCTIONS OF THIS POSITION.
§ Primarily an office setting environment with moderate noise levels and no direct exposure to hazardous physical substances.