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Regulatory Operations Publishing Specialist

BD San Jose ,CA
  • Posted: over a month ago
  • Full-Time
  • Benefits: dental, life_insurance, medical, vision, 401k
Job Description

Job Description

The Global Regulatory Operations, Publishing Specialist, manages and executes Regulatory Submission Publishing supporting the Global Regulatory Affairs team in the medical segment. This position will be a key conduit/liaison between the Medical Segment and Corporate Regulatory Operations programs to drive quality and consistency in electronic submissions to Regulatory Authorities.

Apply Link:

https://jobs.bd.com/job/salt-lake-city/regulatory-operations-publishing-specialist/159/16284029​

 

Responsibilities:

  • Planning, review and assembly of regulatory submissions to FDA, such as 510(k)’s and IDE’s. Independently finalizes and submits high quality, regulatory submissions electronically to the FDA within company timelines and in accordance with regulatory guidelines for eCopy.
  • Planning, review, assembly and record management of regulatory submissions to the EU Notified body, such as EU MDR and IVDR Technical Documentation. Manage Notified Body electronic gateway and ensure electronic submission compliance as required.
  • Format Regulatory Submissions according to standardized templates, and support/train segment on use of templates and Style Guide.
  • Maintains and tracks regulatory submission documentation, including regulatory authority correspondence, in an appropriate document management system or hardcopy archive location to ensure regulatory compliance and in accordance with company document standards.
  • Maintains appropriate documentation of tasks, project plans, and activities performed.
  • Participate in Regulatory Operations process improvement and system initiatives.
  • Provide support for Regulatory Systems; such as DMS.
  • Foster and maintain relationships with the strategic Global Regulatory Affairs organization and other functional partners to ensure understanding of current processes and optimization for BDX processes.
  • Support centralization of common documentation in support of global registration activities and processes

Essential Job Functions:

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

  • Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance, sets priorities within area of purview, and ensures adequate workload balance through interactions with other team leads and management.
  • Serves as part of the corporate Regulatory Operations team that drives the strategy for shared services support.
  • Skilled at technology such as Adobe Acrobat, MS Word, MS Teams, Sharepoint, Excel, power point.
  • Implement publishing processes across multiple complex regulatory documents;
  • Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution;
  • Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents

Basic Qualifications:

  • Knowledgeable of submission and publishing requirements and tools
  • Excellent experience and knowledge of PC/database skills
  • Experience and knowledge of document management systems
  • Excellent analytical and problem solving skills
  • Sound working knowledge of the Global regulatory environment

Education and/or Experience:

  • Bachelor’s Degree in a scientific or other related discipline; minimum 1-3 years experience with regulatory publishing requirements for medical devices, pharmaceuticals or biotech industries.
  • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
  • Strong personal leadership and self-direction. The individual must be able to self-manage parallel priorities and complete daily workflow based on general instructions.
  • Demonstrated ability to work with, coordinate, and prioritize demands from multiple stakeholders.
  • Ability to work in a team environment
  • Working knowledge of Medical Device development and approval process, as well as life cycle maintenance
  • Excellent communication skills; both oral and written
  • Specialized technical skills: Experience with electronic submissions (FDA eCopy, eCTD, etc) preferred. Full ability to use PC based software programs (i.e. Microsoft Word, Excel, Powerpoint, Access, and Adobe Acrobat) required. Ability to successfully use Corporate-wide software programs such as MS Teams, Sharepoint, MasterControl/SAP,and others, as applicable.
Company Description
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

ABOUT BECTON DICKINSON (BD):

One of the most highly respected Medical Technology Companies in the world, Becton Dickinson has been leading healthcare safety and technologies for more than a century. We are over 64,000 associates strong and growing!

At BD Becton, Dickinson & Co., you are one person making one big difference. You are a key member of a team that is an important part of a leading, purposeful company committed to advancing the world of health. No matter what role you play, you can be confident that you are improving lives, all over the world. And as you progress with us, your impact will only grow.

BENEFITS:

BD provides comprehensive total rewards benefits for all of its employees. Most benefits start on day 1 of your employment with BD.

· Competitive pay

· Up to 6 weeks of paid parental leave

· Medical, dental, and vision insurance plans

· Education assistance

· Adoption assistance

· 401K plan with $.75 of every dollar matched up to 6% of compensation

· Basic life and AD&D provided

· Discounted home, auto, and pet insurance plans

· Paid holidays and vacation (pro-rated the first year based on actual start date)

BD

Why Work Here?

Become part of a company that makes a difference in human health, saving and improving the lives of people in all corners of the globe.

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare. Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness. ABOUT BECTON DICKINSON (BD): One of the most highly respected Medical Technology Companies in the world, Becton Dickinson has been leading healthcare safety and technologies for more than a century. We are over 64,000 associates strong and growing! At BD Becton, Dickinson & Co., you are one person making one big difference. You are a key member of a team that is an important part of a leading, purposeful company committed to advancing the world of health. No matter what role you play, you can be confident that you are improving lives, all over the world. And as you progress with us, your impact will only grow. BENEFITS: BD provides comprehensive total rewards benefits for all of its employees. Most benefits start on day 1 of your employment with BD. · Competitive pay · Up to 6 weeks of paid parental leave · Medical, dental, and vision insurance plans · Education assistance · Adoption assistance · 401K plan with $.75 of every dollar matched up to 6% of compensation · Basic life and AD&D provided · Discounted home, auto, and pet insurance plans · Paid holidays and vacation (pro-rated the first year based on actual start date)

Address

San Jose, CA
USA

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