Staff Regulatory Affairs Specialist, International

2 months ago

San Diego, California, United States BD (Becton, Dickinson and Company) Full time

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 healthTM 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.

Job Overview:

This position is responsible for support of a variety of international related regulatory activities and projects, and/or personnel. This position is responsible for developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies.

Key responsibilities:

· Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.

· Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders.

· Proactively lead regulatory efforts required to comply with new regulations and requirements; i.e., Canada, Latin America, EU MDR, MDSAP.

· Review protocols and reports to assure collection of appropriate data for global regulatory submissions and regulatory compliance.

· Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

· Prepare global strategies for changes to commercialized products. Work cross-functionally and lead cross-functional teams to implement global updates.

· Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about potential impact.

· Identify ways to improve the efficiency of current work process and execute them.

· Performs other duties and assignments as required.

Professional Skills & Key Competencies

  • Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.
  • Effectively communicate information to peers and all levels of management.
  • Translate regulations and guidelines into terms that other functions can understand and apply.
  • Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.
  • Solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
  • Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
  • Strong influencing skills. Establishes process and provides expertise for a specific area.

Qualifications:

  • Bachelor's degree required. Master's degree in life sciences preferred.
  • 5 years of Regulatory Affairs experience in the medical device industry preferred
  • Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.
  • Sound understanding of design control processes, FDA, and global regulations and standards.
  • Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.
  • Excellent interpersonal, communication and analytical skills.

Preferred Skills & Knowledge:

Familiarity with infusion pumps, safety assurance cases, and cybersecurity.

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

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

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA AZ - Tempe Headquarters, USA CA - Milpitas 135, USA GA - Covington BMD, USA IL - Vernon Hills, USA NJ - Franklin Lakes, USA TX - San Antonio

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

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.


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