Job Description Summary

BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist in San Milpitas, CA. The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices as well as research use only (RUO) products in global markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. It also requires identifying required documentation, management of submission to worldwide RA partners and working with cross functional teams to ensure that all data and information required for regulatory submissions and approvals are generated.

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 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.

Summary:

The Senior Regulatory Affairs Specialist will be responsible for providing support to all aspects of regulatory affairs activities including managing registration submissions, obtaining approvals, maintaining registrations, conducting market surveillance activities, preparing regulatory submissions and supporting product development efforts. The candidate should have outstanding communication abilities and a deep understanding of regulations pertaining to medical devices. The Senior Regulatory Affairs Specialist will work closely with cross-functional teams such as Marketing, Engineering, Quality Assurance/Control, Finance, Legal Counsel etc., to ensure compliance with local laws and regulations while meeting business objectives.

Responsibilities:

• Manage the regulatory process by interacting directly with country RA partners and government agencies; provide updates on status of applications submitted to appropriate internal stakeholders; coordinate meetings between relevant departments when necessary; oversee submission package preparation including compilation of documentation required under applicable law or regulation; review draft documents prepared by others prior to submission; prepare correspondence regarding outcomes of submissions; respond promptly to queries received during evaluation period; liaise effectively between internal departments & external authorities throughout entire lifecycle of application until final decision has been made; participate actively in negotiations where required; contribute meaningfully towards resolution of any issues raised by authorities during evaluation phase so that timely decisions can be reached without unduly delaying progress toward ultimate goal – successful commercialization of products within targeted markets globally.
• Collaborate closely with internal functions such as Marketing, Sales, Technical Support etc., to understand customer needs better; identify potential areas where improvements could be made to enhance overall performance of existing products; develop strategies aimed at maximizing opportunities for growth through innovative solutions designed specifically around those requirements; leverage expertise gained via experience working across multiple disciplines to drive forward initiatives which benefit both organization and customers alike.
• Monitor changes in legislation relating to medical device industry; stay abreast of emerging trends affecting regulatory landscape globally; keep up-to-date records of key events occurring within sector; identify implications arising from new policies implemented by governments; assess impact on current operations; devise plans accordingly so as not to disrupt normal functioning of business units.
• Conduct regular audits to ensure compliance with relevant regulations governing medical devices; identify gaps if any exist between actual practices employed by organization versus standards set forth by authorities; implement corrective measures swiftly whenever deficiencies are detected.
• Work collaboratively with internal stakeholders such as R&D, Quality Control, Manufacturing etc., to gather information pertaining to safety and effectiveness of products being developed; collate data obtained from various sources into comprehensive reports detailing findings; present results accurately & concisely to management team; provide feedback based upon analysis undertaken.
• Coordinate testing procedures carried out on finished goods prior to their release onto market; review test protocols carefully before they are executed; evaluate results obtained after completion of tests; determine whether or not products meet all criteria specified under applicable law/regulation.
• Provide guidance to other departments within organization on matters relating to regulatory affairs; offer advice whenever requested by colleagues who may require assistance understanding complex rules governing medical device industry.

Required Skills/Experience:

• Minimum 5 years’ experience working within regulatory affairs environment preferably focused on medical devices industry.
• Experience MUST be within a REGULATED Industry (examples; Medical Device, Aerospace, Automotive, Pharmaceutical)
• Strong analytical skills coupled with ability to think critically & solve problems independently.
• Excellent interpersonal skills with proven track record of building effective relationships internally & externally.
• Ability to communicate clearly & concisely both verbally & written form.
• Proven ability to manage multiple projects simultaneously while meeting tight deadlines.
• Proficiency in Microsoft Office Suite required (Word, Excel, PowerPoint).

Preferred Skills/Experience:

• Bachelor’s degree in Science, Engineering, Pharmacy or equivalent field preferred but not essential provided candidate possesses sufficient relevant experience.
• Medical Device Industry preferred – will consider other REGULATED Industry experience
• BILINGUAL Chinese/Mandarin would be beneficial but not essential.

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.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 155

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)

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 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