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Job Description SummaryThe Senior Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration (FDA) and the EU In Vitro Diagnostic Regulation (IVDR). This individual will be responsible for leading the regulatory support for IVD new product development, developing regulatory strategies, submissions to FDA and an EU notified body, maintenance of legacy products, and special projects. Furthermore, this individual is responsible for, reviewing policies, guidance documents and procedures; applying best practices; and collaborating with cross-functional teams (e.g., R&D Quality, Clinical Operations, etc.) within the business units to support the total product lifecycle.Job 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 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 entrepreneurial 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.Activities Include but are Not Limited to the Following:
Represents RA in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues, and identifying solutions, through the product development cycle and coordinating cross functional team inputs.
Responsible for assessing and documenting regulatory pathways for new products and product modifications while working with cross-functional teams to ensure alignment of the global regulatory strategy with business objectives and implementation of the strategic plan.
Identifies and communicates potential risks and mitigations associated with the regulatory strategy and submission.
Review and approval of design control related documents and labels, labeling, and promotional materials.
Leads and prepares high-quality regulatory submissions such as Pre-Submissions, IDEs, 510(k)s and/or EU Technical Documentation (IVDR) with limited supervision.
Coordinates interactions/negotiations with U.S. and EU regulatory agencies. Obtains approval from health authority(ies) with desired claims, per project plan.
Reviews and supports product design changes through regulatory assessments, and implements required regulatory actions (e.g., authors Letters to File and/or updates technical document).
Supports annual reviews with internal/external audits.
Assists in implementing department procedures and maintaining regulatory requirements.
Responsibilities will entail problem solving of moderate complexity issues, involvement in a diverse scope of project results, data analysis, and ownership of task execution and completion.
Provides support to RA manager and RA leadership, supports other RA teams (e.g., EU and international) when required, and performs other related duties and assignments as required.
Education and Experience:
B.S. degree in health science or life science field (e.g., biomedical engineering, engineering, computer science, biology, medical technology, chemistry or related science, etc.). RAC Certification is a plus.
Typically requires a minimum of 3 years’ experience working in an ISO or U.S. FDA regulated environment and medical device industry, preferably in the area of regulatory affairs.
Demonstrated experience in authoring a 510(k), leading pre-submissions, and interact with FDA to obtain clearance, preferably an IVD.
Ability to interpret new regulations and understand and interpret IVD regulatory requirements.
EU (IVDR) experience is a plus.
Flow cytometry experience is a plus.
Knowledge and Skills:
Typically requires 3 years of U.S. submission and EU Technical Documentation experience for IVD instruments, software, and/or reagents.
Familiar and/or experience with regulatory requirements for IVD manufacturers such as design control requirements, change notifications, device listings, site registrations, etc.
Excellent project management, negotiation, communication (written and verbal) and social skills; ability to communicate and work in a team with varied strengths environment; effective interactions with technical personnel (scientific and legal).
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
Detail oriented, with emphasis on accuracy and completeness. Including the ability to write high quality submission or internal documentation.
Excellent team skills with ability to influence others without authority.
Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
Ability to identify areas of concern in moderately complex projects and lead changes.
Demonstrated organizational and planning skills, including process savvy, committed, focused urgency and working towards results.
Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).
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.To learn more about BD visit https://bd.com/careersBecton, 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-PROPrimary Work LocationUSA CA - Milpitas 155Additional 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 Our Commitment to You (https://jobs.bd.com/benefits) .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$103,500.00 - $170,800.00 USD AnnualBecton, 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.
Vacancy caducado!