Sr. Staff RA Specialist - Software (Remote)

Job Description Summary

Job Description

We are the makers of possible

BD 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 creativity 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 bold 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.

Job Summary:

BD is seeking a medical device Senior Regulatory Affairs specialist with experience supporting Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) to work closely with our agile software development product teams. The Regulatory specialist has extensive experience collaborating with software development teams, can effectively communicate regulatory requirements to software engineers, and provides mentorship in applying regulations using methodologies that facilitate agile software development practices. This position also requires strong project management and communication skills to define the project plans and lead the execution of sophisticated cross-functional regulatory initiatives with regular status updates to organizational leadership.

Responsibilities:

• Collaborates closely with software development teams to provide ongoing (sustaining) mentorship and support for regulatory requirements and compliance standard processes with broad expertise in SaMD/SiMD product development, regulatory submissions, and quality management.
• Advising on software development processes and their compliance with global medical device regulations and providing support for ongoing process improvements, compliance activities, and readiness for internal and external audits.
• Prepares regulatory submissions and conducts regulatory assessments.
• Ongoing cross-functional support to maintain readiness for internal and external audits and supports in facilitating audits and driving the implementation of corrective actions.
• Understands how to align software development tools and methodologies with regulatory requirements to ensure compliance while maintaining an agile and efficient development and verification process.
• Supports the creation of documentation related to regulatory compliance requirements (i.e. identification of standards and guidance appropriate to specific projects, regulatory plans, submission narratives, review of QMS documentation)
• Assist with strategic planning of software development and verification activities. Ongoing support of software development teams and leadership to prioritize, strategize and continuously improve

Requirements:

• Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO 13485, 21 CFR parts 801, 803, 806, and 820, ISO 13485, 14971, FDA Guidance on Interop, AAMI 2800-1, GDPR, EU MDR, Canadian MDR, and ANVISA.
• Direct experience with Medical Device Software regulations IEC 62304 / 82304, IEC 60601
• 5+ years experience with regulated medical device development
• 5+ years experience collaborating directly with software development teams on regulatory and compliance related activities, specifically related to software development planning (including COTS, configuration and maintenance planning to ensure cohesion with guidance documents and standards and execution of these plans
• Working knowledge of agile software development practices with hands-on experience implementing medical device regulations in agile software development environments (i.e. AAMI TIR-45:2012 Guidance on the use of AGILE practices in the development of medical device software or equivalent knowledge)
• Working knowledge of QMS, leveraging experience in supporting QMS process implementation using methodologies that promote compliant and agile software development practices
• Working knowledge of development, integration and system level verification methodologies and regulatory expectations of the same (i.e. strategy, planning, report)
• Minimum of 5 years' experience working with US 510(k)/PMA and CE Tech Files including software-driven medical devices and related products
• Knowledge of hardware-based device development, compliance testing, and documentation (i.e. traceability, integration, verification) a plus
• Ability to organize information and present to a wide array of audiences

Education:

• B.A. or B.S. degree preferably in a life science field (biology, microbiology, chemistry, engineering, biomedical engineering, software engineering, medical technology, regulatory science, etc.)
• Advanced degree in life sciences (MS, PhD, etc.) and/or MBA encouraged. Certifications (RAC, CQA, CQM, etc.) preferred.

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 extraordinary, we do what's right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and exciting culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

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 creativity and aim 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.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN

#LI-PRO

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At 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 Our Commitment to You.

Salary 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 offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$151,400.00 - $249,800.00