RAQA Executive, Regulatory Affairs - Watson Health
Company: IBM Computing
Location: Cambridge
Posted on: May 12, 2022
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Job Description:
IBM RAQA Executive, Regulatory Affairs - Watson Health in
Cambridge , Massachusetts Introduction At IBM, work is more than a
job - it's a calling: To build. To design. To code. To consult. To
think along with clients and sell. To make markets. To invent. To
collaborate. Not just to do something better, but to attempt things
you've never thought possible. Are you ready to lead in this new
era of technology and solve some of the world's most challenging
problems? If so, lets talk. Your Role and Responsibilities As RAQA
Executive, Regulatory Affairs and member of the Watson Health RAQA
Organization, you will support global Regulatory Affairs for all of
Watson Health. You will use your knowledge of global medical device
regulations and standards to support the development of products
for Watson Health. You will interface with the business and
marketing leaders, the solution teams, regulatory, legal and other
stakeholders to maintain compliance for the products. This position
is located in our Cambridge, MA location. Acts as company
representative, developing and maintaining positive relationships
with device reviewers through oral and written communications
regarding post-market submissions, pre-submission
strategy/regulatory pathway development, testing requirements,
clinical study requirements, or clarification and follow up of
submissions under review. Participates or leads FDA, notified body,
and other regulatory bodies audits Work with regulatory experts to
ensure the practice/organization has and maintains appropriate
compliance forms, information notices and materials reflecting
regulatory requirements for the target markets for Watson Health
and Watson Health Imaging. Evaluates proposed products for
regulatory compliance requirements internationally Ensures the
development of quality and regulatory procedures for incorporation
into the QMS to support target markets Ensures compliance and
supports regulatory applications, as well as internal regulatory
file documentation to achieve market clearances in US, Canada, EU,
Brazil, Japan and Australia as applicable. Collaborates with
regional business partners to support international product
registrations. Leads the development of regulatory department
policy and procedure implementation. Reviews device labeling and
promotional materials for compliance with global submissions and
applicable regulations. Stays current on new regulations through
regulatory intelligence monitoring. Performs all duties and
responsibilities as required by the Quality Management System
Policies and Procedures Build quality into all aspects of their
work by maintaining compliance to all quality requirements Leads
cross functional teams for assigned projects Coaches, mentors and
trains junior staff members Basic Qualifications BA/BS in a
scientific discipline including a minimum of 20 years in healthcare
medical device or life sciences pharmaceutical experience. At least
12-15 years' experience with job title/experience related to
Quality Engineer, Quality Systems or Regulatory Affairs Well versed
in medical device regulations in accordance with USA, Canada,
Brazil, Japan, EU, UK, Australia and Singapore requirements.
Excellent interpersonal, communication, and negotiation skills
Required Technical and Professional Expertise Bachelor's degree in
a scientific or technical discipline required; advanced degree
preferred Preferred professional certifications: RAPS- RAC.
Proficient knowledge of global regulatory submission requirements
for medical devices; software medical devices preferred. General
understanding of product development process and design control
Proficiency with Microsoft Word, Excel and PowerPoint required.
Effective research and analytical skills Effective written and oral
communication, technical writing and editing skills Ability to work
independently with minimal supervision Preferred Technical and
Professional Expertise
Keywords: IBM Computing, Cambridge , RAQA Executive, Regulatory Affairs - Watson Health, Healthcare , Cambridge, Massachusetts
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