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Senior Clinical Regulatory Affairs Specialist I

Date:  Sep 23, 2021
Location: 

Danvers, MA, US, 01923

Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,300 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

 

Are you a strong Regulatory Affairs professional who is fulfilled by contributing to an incredible mission, and seeing the tangible results of your work? Do you enjoy working with outstanding team members to generate wins for patients in need? If so, consider the following opportunity with ABIOMED's growing Regulatory Affairs team! The Senior Clinical Regulatory Affairs Specialist will be responsible for preparing regulatory documents and submissions according to Abiomed standards. Reporting directly to the head of our Global Regulatory Affairs organization, you will work closely with Regulatory Affairs, Clinical Operations and Medical Office team members, as well as other cross-functional staff members to support Regulatory and Clinical programs. Through your engagement in this role, you will help shape the life-saving field of heart recovery!

The ideal candidate for this opportunity will:

  • Be passionate about Regulatory Affairs impact on the clinical research, development, indications, and marketing aspects of state-of-the-art class III cardiovascular medical devices.
  • Be energized by joining a world-class company and regulatory team!
  • Enjoy teamwork and thrive as a member of dynamic cross-functional clinical project teams
  • Build and maintain strong interpersonal relationships within and outside of the company
  • Exhibit natural leadership traits: positive attitude, forward-looking, accountable, action-oriented, a focus on delivering results
  • Be adaptable and thrive in a dynamic work environment where variety is the norm
  • Embrace change, continuous learning, and work skills improvement
  • Enjoy successfully prioritizing various competing priority tasks

As a Senior Clinical Regulatory Affairs Specialist with ABIOMED, you will:

  • Lead the planning, writing, review, submission and curation of FDA submissions and associated regulatory documents relevant to clinical trials, including but not limited to IDE & IDE supplements, FIH studies, Post-Approval Studies, 510ks, PMA & PMA Supplements, related annual reports.
  • Provide regulatory input to development and implementation of clinical regulatory strategies and plans throughout the product lifecycle that are consistent with business unit goals and objectives
  • Serve as the primary regulatory functional representative on clinical projects, ensuring that regulatory requirements are fully understood, incorporated and/or mitigated
  • Communicate regulatory plans and project status to internal stakeholders
  • Communicate with regulatory agencies (FDA) regarding clarification and follow-up of submissions under review
  • Coordinate efforts associated with the preparation of clinical regulatory documents and submissions for FDA
  •  Compile and maintain clinical regulatory documentation databases and tracking systems
  • Participate in internal and external BIMO audits
  • Follow changes of the regulatory landscape, identify impact, develop solutions to maintain regulatory compliance

Required Education / Experience / Qualifications:

  • Bachelor's Degree in Engineering or Science required (advanced degree preferred)
  • Minimum of 5 years of technical, scientific and/or clinical experience in the medical device industry (Class III medical device experience strongly preferred)
  • Minimum of 5 years of experience working in a Clinical Regulatory Affairs role with an emphasis on supporting US-based clinical trials and research
  • Excellent communication (written and verbal) and organizational skills

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.


Nearest Major Market: Boston