Principal Regulatory Affairs Specialist

  • Brooks Automation
  • Indianapolis, IN, USA
  • Feb 14, 2020
Full time Government

Job Description

At Brooks, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity Job Title Principal Regulatory Affairs Specialist Job Description

The Principal Regulatory Affairs Specialist supports the business line leader in building new/incremental service lines by providing guidance on the regulatory environment and the customer requirements that need to be met to ensure successful customer adoption of the new services. In this role, you will combine regulatory and business development expertise to partner with internal stakeholders by providing regulatory guidance.

Major Responsibilities, Activities and Task Statements:
  • Works with business line leader to understand the global regulatory environment and define which accreditations/certifications are required to support the overall business strategy.
  • Defines what other business processes and systems need to be adapted, improved or created to ensure the new service can be successfully deployed.
  • Prepares comprehensive regulatory strategies for new product and service offerings.
  • Research global regulatory requirements and prepare gap analysis for meeting requirements based on current business structure.
  • Provides recommendation to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight.
  • Generate business plan, including budget, for obtaining required licenses and permits, as well as recommended accreditations and certifications
  • Create and submit applications to regulatory, certifying and accrediting bodies and ensure timely renewal.
  • Collaborate with global BLS functional areas and ensure compliance to College of American Pathologists (CAP), FDA [Good Laboratory Practices, Good Manufacturing, Good Tissue Practices, Good Clinical Practices, Good Distribution Practices, 21CFR, Part 11], VAWD, Quality Control procedures and standards of operation.
  • Create, maintain and/or follow proper quality system procedures and maintain up-to-date knowledge of applicable state, national / international applicable regulations, standards, guidelines and regulated industry trends.
  • Participate in Regulatory inspections, Notified Body and other 3rd-party Quality System audits as required. Perform regulatory audits of all BLS global locations as required.
  • Works with other functional areas and appropriate resources to develop and implement compliance and appropriate Regulatory and Quality Assurance policies.
Minor Responsibilities, Activities and Task Statements:
  • Drive continuous improvement initiatives, develop and monitor effective performance metrics, and coach and develop department leaders.
  • Actively participate in meetings as required such as in-service meetings, committee meetings, department meetings, etc.
  • Work cooperatively withal members of BLS Management team to achieve company goals.
  • Performs other duties as directed by Supervisor.
Position Specifications

Required
  • Four-year degree in science related field
  • Minimum of 7 years of experience in a Regulatory position within the life sciences industry.
  • Working knowledge of pertinent CLIA/CAP/ISO/FDA/EU/etc. regulations, standards and guidance documents that dictate compliance qualifications.
  • Strong research, analytical, and problem-solving skills.
  • Ability to set priorities and adapt to changing business needs and manage multiple projects within established time frames.
  • Ability to clearly and effectively communicate complex issues and concepts both written and verbal
  • Strong communication and interpersonal skills.
  • Experience writing and managing SOPs and Policies
  • Demonstrated high level of initiative and ability to work independently and within a team.
  • Proven ability to work effectively with teams.
  • Competency with Microsoft Office products including Outlook, Word and PowerPoint.
Preferred
  • Experience in clinical supply
  • Multi-lingual
If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at for assistance.

Brooks Automation is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.