Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Irvine, California
PRINCIPAL REGULATORY AFFAIRS SPECIALIST
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.
Individual contributor who is a member of a project team and develops / implements strategies and prepares submissions for the earliest possible approvals by FDA, Notified Body, Health Canada. Manages regulatory communication, filing strategy, negotiations, correspondence tracking, submission development, query responses and other assigned regulatory activities for Endologix products. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments (e.g., R&D, Quality and Mfg.) and outside regulatory representatives (i.e., FDA, Health Canada, and Notified Body) in a respectful, professional manner.
* Represents Regulatory on assigned project teams to provide guidance and ensures adherence to regulatory requirements, as applicable
* Mentors, trains, and develops junior regulatory affairs staff members. Provides regulatory support to currently marketed products. This includes, for example, changes to labeling, design, processes to obtain regulatory approval, where required
* Manages query resolution to agreed-upon timelines in collaboration with cross-functional teams
* Maintains up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensures effective communication to project teams
* Develops, justifies and documents regulatory strategies to support company goals
* Performs other duties as assigned by Regulatory Affairs Management
* 10-20% travel is anticipated
* Bachelor's degree in a scientific discipline or equivalent is required.
* Minimum 10 years in Regulatory Affairs
* Demonstrated experience with successful submissions and strategic planning
* Experience with US Class III cardiovascular devices strongly preferred
* Strong interpersonal skills including ability to interact with a high degree of diplomacy and to effectively collaborate with project teams and other departments
* Self-motivated, self-disciplined and able to prioritize / manage / complete multiple tasks and responsibilities within the committed timelines
* Ability to work in a fast-paced, technically challenging environment
* Extensive knowledge of medical device regulations and product development processes
* Good project management skills and ability to appropriately adjust priorities
* Excellent applied thinking and technical writing skills
* Strong communication and organizational skills
Leadership Core Competencies:
* 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
* Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results
* Selecting & Developing Talent: Coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels
* 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
* Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups, and looks at the company holistically
* 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
* 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
* Problem Solving & Problem Prevention: Uses strong problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
* 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
* 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
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, 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
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.