Sr. Regulatory Affairs Specialist

Overview

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.

We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.

With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.

Overview:

The Senior Regulatory Affairs Specialist represents the Regulatory Affairs function in assigned project teams and completes projects and tasks to established timelines to meet corporate objectives. Ensures compliance with state, federal and International medical device regulations, and overall regulatory department objectives. Develops, prepares, and maintains US and international regulatory filings and documentation and interacts with regulatory authorities to achieve timely approvals.

Responsibilities

Key Responsibilities:

• • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
  • In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends strategy and pathway that appropriately weighs the probability of success with potential risks to the business. With minimal Regulatory Affairs management oversight, develops sound regulatory strategies to support business goals.
  • Independently assesses product and manufacturing changes and develops regulatory assessments for each global market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs) for those deemed to meet the threshold for not requiring prior approval.
  • Reviews and approves CAPA plans and reports, feasibility test protocols and reports, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams.
  • Interacts with representatives of the notified body and regulatory bodies in the US and internationally in a respectful, professional manner to ensure regulatory submission projects remain on track and issues or queries are identified and resolved in conjunction with project teams as expediently as possible.
  • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US, Europe (CE Mark and local registrations), and other international areas. Establishes timelines, manages sub-team meetings relevant to the regulatory processes, and ensures timely execution.
  • Prepares reports for management and develops metrics and proposals for regulatory process improvements.
  • Develops timelines and oversees project teams, manufacturing, complaint handling, and marketing department assigned representatives to prepare and submit annual reports to the US FDA and international authorities.
  • Represents the Regulatory Affairs function in internal and external audits of the Endologix Quality System. Serves as regulatory subject matter expert for areas related to project responsibilities. Provide support to external audit activities as needed.
  • Under the direction of Regulatory Affairs management, executes regulatory aspects for any field corrective actions in a timely, thorough, and transparent manner. Develops reports for submission to global regulatory authorities and responds to requests for information.
  • Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
  • Updates departmental procedures as required.
  • Perform other duties as assigned by Regulatory Affairs Management
  • Up to 20% travel is anticipated.

Qualifications

Qualifications:

• Minimum bachelor's degree in a scientific discipline or equivalent
• Minimum 5 years of experience with a Bachelor’s degree, 3 years of experience with a Master’s degree, of directly relevant experience in Regulatory Affairs.
• Experience with US Class III cardiovascular devices strongly preferred.
• Strong interpersonal skills including ability to interact with high degree of diplomacy.
• Extensive knowledge of global medical device regulations.
• Experience in developing and communicating global regulatory strategies
• Comprehensive knowledge of quality systems and relationship to business.
• Ability to facilitate and provide leadership when interpreting regulatory standards and guidances.
• Comprehensive understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Product development team experience
• Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities within the internal commitment dates.
• Effective problem-solving techniques.
• Excellent applied thinking and technical writing skills.
• Strong communication and organization skills required.
• Expertise in Microsoft Office applications programs.

Expected Base Salary: $85,000- $123,250 (Compensation will be commensurate with experience and expertise.)

At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. We work hard to bring life changing products to patients and believe that a culture which is inclusive of our individual backgrounds and passions will help us create ideas that move all of us forward.

As a global business, our ability to understand, embrace and operate in a multicultural world – in the marketplace and workplace – is critical to our success. Many employees across the company work diligently to help us advance in our diversity journey. Employee feedback gathered both formally and informally further strengthens our culture of inclusion and collaboration as well as initiatives focused on gender and U.S. ethnicities.

Join us, and bring your point of view, talents and contributions so we can all grow together.

Salary : $85,000 - $123,250