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Senior Regulatory Affairs Specialist - SaMD/Software

Date:  Aug 7, 2022
Location: 

US

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 Regulatory Affairs Specialist - SaMD/SW  serves as the Subject Matter Expert and primary regulatory lead on projects involving Software as a Medical Device (SaMD), Software, artificial intelligence, and digital health.  The Senior Specialist collaborates across the organization on new products, new technologies and sustaining current products with a focus on Software (SW) and Software as a Medical Device (SaMD).  This key team member will play a crucial role in ensuring that new technologies are available to patients in need, and will play a significant role in the growth of our predictive AI and software portfolios.  Through your engagement in this role, you will help shape the life-saving field of heart recovery!  *This is a remote opportunity! #LI-Remote 

 

Principal Responsibilities:

  • Regulatory subject matter expert in Software and Software as a Medical Device
  • Regulatory lead/representative on core project teams (new product development, sustaining, etc) providing regulatory input on all matters
  • Develops global regulatory strategies to support business growth plans.
  • Plans and prepares needed regulatory submissions and associated documents with a focus on the US and with a global perspective
  • Performs and advises on regulatory impact assessments for product changes
  • Interfaces with outside consultants as needed
  • Conducts training programs to educate employees on regulatory processes and requirements
  • Communicates with regulatory agencies regarding clarification or follow-up of submissions under review
  • Reviews technical documents for incorporation into regulatory submissions
  • Maintains company registration and device listings for global regulatory agencies
  • Regulatory liaison/representative in internal or external audits
  • Maintains current knowledge base of existing and emerging regulations, standards and guidance documents
  • Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
  • Prepares and maintains technical files as necessary to obtain and sustain product approvals
  • Compiles and maintains regulatory documentation databases and tracking systems as necessary

 

Required Qualifications:

  • 5+ years of Regulatory Affairs experience in the medical device industry with a track record of successful submissions in software and/or SaMD
  • Experience preparing & defending regulatory submissions to the FDA, specifically relating to SaMD and software, similar global experience a plus
  • BS degree or higher preferably in the engineering or software-related disciplines
  • Understanding of the software development lifecycle, systems integration, system and software testing, and cybersecurity requirements and regulations
  • Willingness & ability to travel to Danvers, MA headquarters approximately once a month (10-15% of the time)


General Qualifications: 

  • Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
  • Outstanding written and verbal communication skills
  • Keen ability to prioritize work and execute in an environment of competing priorities
  • Strong organizational skills
  • Strong technical / computer skills 

Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption

 

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.