Represents the Regulatory Affairs function, and completes projects and tasks to established timelines to meet corporate objectives. Ensures compliance with state and/or global medical device regulations, as assigned, and overall regulatory department objectives. Negotiates the content and structure of regulatory filings with international partners, agents, and distributors. Develops, prepares, and maintains US and/or international regulatory filings and documentation and supports interactions with regulatory authorities to achieve timely approvals.
(To perform the job successfully, an individual should demonstrate the following competencies):
· Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
· Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
· Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
· Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
· Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
· Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
· Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
· Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
· Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
· Equipment Use: Copy machines, fax machines, calculators and 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 groups of managers, clients, customers, and the general public.
· Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. 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
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800