Endologix, Inc

Regulatory Affairs Project Manager

Job ID
2017-1780
US-CA-Santa Rosa

Overview

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.

 

Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental objectives. Develops, prepares, and maintains domestic and international regulatory filings and documentation to meet corporate objectives.

Responsibilities

  • Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
  • Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and management.
  • In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in identified regions globally.
  • In collaboration with the international regulatory team, manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis.
  • Directly interact with regulatory bodies in the US and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
  • Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate.
  • Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams.
  • Manage the preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications and annual reports; marketing applications and annual reports to US and international regulatory authorities.
  • Manage query resolution process using sound project management skills and to agreed upon timelines in collaboration with cross-functional technical teams.
  • Coordinates with RA international staff and internal support staff to support basic file preparation as needed. 
  • Update departmental procedures
  • Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication. 
  • Perform other duties as assigned by Regulatory Affairs Sr. Management.

  • Up to 30% travel is anticipated

Qualifications

Education:

  • Minimum bachelor’s degree in a scientific discipline or equivalent.

Experience:

 

  • Minimum 9 years of experience with a Bachelor’s degree, 7 years of experience with a Master’s degree of directly relevant experience in Regulatory Affairs.
  • Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred.

Specific Skills, Knowledge & Behaviors

 

(To perform the job successfully, an individual should demonstrate the following competencies):

·         Strong interpersonal skills including ability to interact with high degree of diplomacy.

·         Good project management skills.

·         Extensive knowledge of global medical device regulations and product development processes.

·         Comprehensive knowledge of quality systems and relationship to business.

·         Experience in developing and communicating global regulatory strategies

·         Provide leadership, creativity, and business acumen when interpreting regulatory standards and guidances. 

·         Ability to work in a fast-paced, technically challenging environment where drive is critical to success

·         Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities

·         Expertise in Microsoft Office applications and charting programs.

·         Effective problem solving techniques

·         Excellent applied thinking and technical writing skills

·         Strong communication and organization skills required.

 

Supervisor 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: Assesses, selects, 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

 

 

Core 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

 

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

 

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