Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

BD

  • Irvine, CA
  • $102,000-168,200 per year
  • Permanent
  • Full-time
  • 21 days ago
Job Description SummaryJob DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.This position is part of the Advanced Patient Monitoring (APM) business unit within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD atCompany Overview: Join our innovative team at BD Advanced Patient Monitoring, a leading MedTech company dedicated to revolutionizing healthcare through cutting-edge technology and advanced algorithms. We are committed to improving patient outcomes and enhancing the quality of life through our advanced hemodynamic monitoring solutions. This role supports the Sustaining activities for disposable devices used with monitoring systems.How you’ll make an impact:
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately sophisticated conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
  • Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy
  • Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
  • Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., 510(k)’s and CE marking technical files)
  • Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
  • Review labeling content product and process changes, and product documentation to assure regulatory requirement's compliance, consistency, and accuracy
  • Other incidental duties
What you'll need (Required):
  • Bachelor's Degree in related field
  • A minimum of three to five years of related experience
What else we look for (Preferred):
  • Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Engineering)
  • Experience in preparing domestic and international product submissions
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Excellent written and verbal communication skills including negotiating and relationship management skills
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
  • Full knowledge and understanding of global regulatory requirements for new products or product changes.
  • Full knowledge of new product development systems
  • Good leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.Required SkillsOptional Skills.Primary Work Location USA CA - Irvine Laguna CanyonAdditional LocationsWork ShiftAt BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under .Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information $102,000.00 - $168,200.00 USD Annual

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