Associate, Regulatory Affairs

Job Details: Job Location: JenaValve Technology Inc-HQ - Irvine, CA, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $70500.00 - $75000.00Salary/year, Job Title: Associate, Regulatory Affairs

Job Description Summary: This position supports the organization and maintenance of regulatory affairs and quality system records, procedures, standards, literature, and regulatory documentation to meet company objectives.

Job Responsibilities

Prepare, review, and compile regulatory filings, applications, and technical documentation (such as IDE reports or supplements, Q-subs, PMA reports or supplements, product registrations, FDA small business designation request, CA manufacturing site registration or change reports)
Monitor and research updates in local and global regulations, guidance documents, and standards
Provide administrative support by tracking compliance spreadsheets, manage database inputs and outputs, and organize regulatory meetings or audits
Assists in the paper and electronic (eCopy) preparation and filing of regulatory submissions.
Coordinates international submissions, document apostille/consularization activities as needed.
Monitors global regulations and guidance, and coordinates implementation of product and process changes for ongoing conformance.
Handles requests for payment (including FDA User Fees), assists with expense reports, coordinates travel arrangements.
Organization and maintenance of regulatory files, including copying, scanning, filing and other administrative activities as assigned.
Assists with other RA and cross-functional projects and duties as assigned by manager.

Qualifications: Required Education and Experience:

Bachelor’s degree in a technical field is required (preferably engineering or life sciences), with no prior RA experience
Strong attention to detail, technical writing, organization, and time-management.
Proficiency in MS Office software (Word, Excel, PowerPoint).

Skills and Abilities Required for This Job

Basic project management, communications, interpersonal skills and the ability to understand scientific and health concepts.
Typing, formatting, grammar, editing and proof-reading skills a must
Ability to work in a fast-paced environment where drive is critical to success
Good follow-through and diligence for task completion
Self-motivated and self-disciplined, able to prioritize and handle multiple tasks and responsibilities
The employee must occasionally lift and/or move up to 20 pounds.

Core Competencies

Confidentiality: Preserves confidentiality of product information as appropriate.
Ethical: Aware of impact of ethical behavior by ensuring integrity in personal and organizational practices; respects people and principles, including professional, ethical and human values and may provide training to other departments regarding the importance of ethical behavior and decisions for regulatory compliance.
Regulatory Intelligence: Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities. Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.), maintains information resources and disseminates changes/updates as needed.
Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.
Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.
Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.
Written Communication: Write clearly and informatively; Create documents that are complete and accurate.
Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.
Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.
Equipment Use: Copy machines, personal computers, and computer terminals.
Computer Skills: Software proficiency in Microsoft Office Suite.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from internal and external stakeholders.
Mathematical Skills: Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.