Senior Director of Regulatory Affairs, Europe

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Remote - England, GB

3 days ago Requisition ID: 1317

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA and acquisition by Edwards Lifesciences, we are growing our team – it’s a great time to join Endotronix

WHAT YOU’LL DO

As the Director of Regulatory Affairs, Europe you will oversee all regulatory matters and execute the strategy to ensure the organization complies with applicable European (MDR) regulations and required clinical and commercial approvals. You will develop and lead regulatory strategies while supervising regulatory colleagues responsible for the execution of outputs critical to the company’s business goals. You will implement regulatory strategies concerned with the submission and approval of medical products to government regulatory agencies. Responsibilities:

• Confer with VP of Quality and Regulatory to establish and prepare appropriate European regulatory strategies and filings for product approvals.
• Oversee the development and implementation of global regulatory strategies including US, Europe, UK.
• Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance.
• Provide regulatory support to cross-functional project teams.
• Prepare and submit reports to the European Authorized Representative in a timely and effective manner.
• Prepare and submit for CE Mark approval and expertise in all required documents (GSPRs, PMCF, CERs, etc). Apply for GMDN codes as necessary.
• Prepare technical documentation to enter other regions including the UK, Netherlands, Switzerland, Australia and Canada.
• Maintain current and in-depth knowledge of European and Worldwide Regulatory Authority programs, policies and guidelines.
• Assure that all submission documentation, record keeping and reporting meet inspection standards as established by regulatory agencies worldwide.
• Review, evaluate and approve Document Changes, especially those concerning significant (from a regulatory perspective) changes and revisions.
• Work with QA to ensure that Endotronix is in compliance with MDR, ISO 13485 and state of the art standards for Endotronix products.
• Work with Marketing and others to develop compliant product labeling. Review and approve product labeling for compliance with regulatory requirements.
• Ensure department is aligned and appropriately structured to support European and all global sites.
• Support key R&D, regulatory and business objectives and ensure implementation.
• Develop and manage relationships with external regulatory agencies (e.g BSI), industry groups and business partners. Act as a key corporate regulatory contact for EU market.
• Develop and maintain relationship with internal business partners and key stakeholders to ensure business objectives are met.
• Review, evaluate, analyze and recommend actions on all regulatory issues related to US operations pertaining to product approvals and launch.
• Liaise with Marketing, Quality, R&D, Manufacturing and Operations to provide regulatory strategies during product planning.
• Maintain up to date knowledge on regulatory requirements to assure compliance with current regulations.
• Create, implement and track progress using project plans: manage project resource requirements, and schedule tasks.
• Lead team through the CE-Mark deliverable timeframes ensuring appropriate decision points and must have oversight of review gates, plans and documentation. Develop and maintain a project risk register.
• Report project progress and status to stakeholders.
• Perform other duties as assigned by the VP of Quality and Regulatory.

WHAT YOU BRING TO THE TABLE

• Minimum BS degree in Chemistry, Pharmacy, Life Sciences or Engineering; MS degree desired.
• Minimum 14 years’ experience in the medical device industry with 5-10 years in a senior regulatory affairs role and 5 years of experience in a regulatory affairs management role within the medical device industry.
• Detailed knowledge of EU regulatory and compliance requirements.
• Excellent oral/written communication, leadership, organizational and interpersonal skills.
• Familiarity with IT systems.
• May have experience working within e-QMS software is a plus but not required (We use Grand Avenue).
• Has excellent written and oral communication skills and is comfortable with Microsoft and Google products (Word, Excel, PowerPoint, Gmail, Docs, Sheets).
• Has demonstrated organizational, interpersonal, and critical thinking skills.
• Values integrity and understands the importance of following documented procedures.
• Reliable in following through on commitments and meeting agreed upon timelines.
• Passionate about continuous learning and improvement.

EDUCATION

Minimum BS degree in Chemistry, Pharmacy, Life Sciences or Engineering; MS degree desired.

WHO YOU ARE

• Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers.
• Someone with a bias for action and quick iteration as opposed to perfection.
• A quick learner, who is able to work independently, multitask, and drive your own projects.
• An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results.
• A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts.
• Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale.

WHAT WE’RE LIKE

• Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
• Entrepreneurial, flexible, yet results focused.
• High degree of intellectual curiosity, honesty, and capability.
• Low ego and humble in spirit in spite of your track record of outstanding performance.

LIFE AT ENDOTRONIX

• Our shared company values create a foundation of trust and collaboration. United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians. And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
• We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
• Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability. We are passionately committed to building a diverse organization where all perspectives and cultures are celebrated.