Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.
Oversees global regulatory affairs activities for assigned device (s) and/or geographies. Designs, plans and executes business-aligned strategies for timely and high quality regulatory submissions in close collaboration with marketing, research and development, manufacturing, and clinical affairs partners for optimum achievement of corporate objectives. Manages and mentors regulatory affairs staff. Provides regulatory advice to other departments and executive management. Provides expertise in the interpretation of regulations into practical and workable plans. Together with direct reports, interacts with regulatory agencies. Ensures that the manufacturing facility maintains all required U.S. and International certifications.
Bachelor’s degree in Engineering, Life Sciences or other technical discipline
10 years of related work experience, including:
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
Supervisor Core Competencies:
1. Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed
2. Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results
3. Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels
4. Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level
5. Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically
6. External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products
7. Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team
8. Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
9. Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
10. 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
11. Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
12. Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
13. Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
14. 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
15. Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
16. 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
17. Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
18. 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:
1. Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
2. Computer Skills: Software proficiency in Microsoft Office Suite.
3. Language Skills: English
4. Mathematical Skills:
5. Reasoning Ability: Strong critical thinking and reasoning abilities.
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