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Regulatory Scientist/Senior Regulatory Scientist - Medical Devices

Company: Voisin Consulting Life Sciences (VCLS)
Location: Cambridge
Posted on: June 20, 2022

Job Description:

Working at VCLS is more than just a job, we offer a career. VCLS welcomes junior and senior-level professionals alike, and joining the team means striving for excellence and true understanding of both the regulatory environment we evolve in and how this environment may affect the needs of our clients. If the promise of delivering effective therapies and making them accessible to patients excites you, consider applying for this opportunity.About the Opportunity: In this Regulatory Scientist/Senior Regulatory Scientist - Medical Devices role, responsibilities include:Primary focus on Medical Devices and Combination Products

  • Participate in development plans for Medical Devices and assimilated products (manufacturing and controls, non-clinical, clinical, market access)
  • Participate in regulatory strategy, positioning, and roadmaps for Medical Devices
  • Write, review and assemble high-quality regulatory submissions for medical devices, including combination products regulated as medical devices, such as CE marking dossier and Clinical Trial Application (CTA) dossier/Investigator's Brochure (IB) for clinical trials
  • Participate in Premarket Approval Application (PMA), Premarket notification (510k), De Novo submission, and Investigational Device Exemptions (IDEs)
  • Participate in other relevant projects of the product line such as regulatory strategy, positioning and roadmaps, and client training
  • Ensure compliance of deliverables with US, EU, or other territory regulations and applicable guidelines, including ICH; ensure all communications to the FDA/Health Authorities, both formal and informal, meet internal and external standards of quality and format
  • Communicate clearly with clients and regulatory authorities for assigned projects
  • Monitor, prioritize and supervise project strategy, timelines, and milestones - communicate these to the project team membersPotential opportunities to work on other projects
    • Contribute to the execution of successful projects on medicinal products, diagnostics, and medical devices for Health Tech products: Patient engagement strategy, including clinical decision support (CDS) software that qualify as a Software as a Medical Device
    • Comply with guidance from the International Medical Device Regulators Forum (IMDRF)
    • Conduct a targeted and systematic literature review
    • Identify and communicate potential risks and solutions
    • Facilitate and foster relationships with stakeholders such as patient associations, ARS, and government organizationsThe ideal candidate will possess the following qualifications:Experience
      • Knowledge of Medical Devices/Combination Products as demonstrated through a combination of work experience and academic background.
      • Focused experience with 510(k)'s, De Novos, IDE's, Q-Submissions, PMA's, and HDE's; experience with pre-IND's, NDA's, and BLA's as it pertains to medical devices and combination products; preferred experience includes: IVD-CDx, patient engagement, and Software as Medical Device
      • Good understanding of the medical device development process
      • Prior experience in medical devices, biotech, or related life sciences industry
      • Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies is a plus
      • Prior experience directly interacting with the FDA/Health Authorities is a plus
      • Experience in a consulting environment is a plus
      • BS/BA degree in Life Sciences
      • MS/MA/Ph.D. degrees are a plus
      • Certification: RAC Devices is a plusPersonal attributes and skills
        • Strong writing and communication (written and verbal) skills.
        • Strong attention to detail, organization/multitasking, project management (planning, scheduling, documentation, project control), and teamwork skills.
        • Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting
        • Problem-solving abilities and a self-starter.
        • Professional and courteous work demeanor. A relationship builder with colleagues, clients, and regulatory authorities.
        • Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
        • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat.
        • Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others. Additional Information
          • Equal Opportunity Employer
          • All resumes are held in confidence
          • Must be eligible to work in the USAbout the CompanyVoisin Consulting Life Sciences (VCLS) is a team of 200+ life sciences professionals specialized in consulting services to innovative life sciences companies: biotechnology, healthtech, and pharmaceutical companies. VCLS supports its clients throughout product development from the design of global development plans and regulatory strategies to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of health products: drugs, biologics, cell and tissue therapies, medical devices/ digital, In-Vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals.With team members based across Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland, Copenhagen, Denmark), the USA (Cambridge, MA and Somerville, NJ), and Asia (China and India (Bangalore)), VCLS is constantly searching for talented people attracted by innovation, geographical and cultural diversity of the organization and its clients, and by the very rewarding and stimulating career opportunities offered to the employees.

Keywords: Voisin Consulting Life Sciences (VCLS), Cambridge , Regulatory Scientist/Senior Regulatory Scientist - Medical Devices, Healthcare , Cambridge, Massachusetts

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