Quality & Regulatory Project Manager - Watertown, United States - Exergen Corporation

Exergen Corporation
Exergen Corporation
Verified Company
Watertown, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description
_
Exergen Corporation_ _is the recognized world leader in medical non-invasive temperature technology.

Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.

_

  • Our Temporal Scanner is the most efficacious, noninvasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 12 million consumers use one at home._
  • Founded by Harvardresearch scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA._

Quality & Regulatory Project Manager
Reports to VP of Quality Assurance and Regulatory Affairs.


Key Responsibilities and Activities:

-
This position will be managing the new product line. The QA/RA manager will collaborate with the company's cross functional team to bring the new product line within technical, clinical and market applicable standards.

  • Create and manage product/project database to record the history of the DermaTemp (DT) medical device product release and continuous maintenance.
  • Develop the product line release plan(s) including key milestones and timelines.
  • Work with the Regulatory lead and Quality team to draft meeting requests and supporting briefing packages for engagements with the cross functional team.
  • Review data from contributing departments and provide comments to ensure accurate and complete documents for inclusion in the applicable regulatory standards (UDI, IFU, Labeling, Packaging, Marketing).
  • Serve as a key member of the matrix regulatory team including generation of meeting agenda and minutes. Contribute to the generation and review of regulatory strategy documents.
  • Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.
  • Work with departmental leaderships to maintain and continuously improve an EN ISO 9001current version, ISO 13485, EN ISO 60601 versions and others.
  • Participate in the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, and training program. Make recommendations for corrective action necessary to ensure conformity with quality specifications.
  • Participate in crossfunctional subteams focused on the execution of regulatory strategy.
  • Contribute to the improvement/development of department policies, procedures (RA SOPs), and best practices commensurate with the applicable requirements of rapidly growing submissions/approvals in multiply WW countries.
  • Assist in managing the regulatory information management system (RIMS) and support the Quality function with the implementation of a new eQMS and in updating the current processes within QMSR.

Required Education and Experience:


  • BS or MS in scientific discipline with at least 710 years of direct experience in Quality Assurance and Regulatory
Affairs in the Medical Device industry.

  • Experience leading projects in the medical device regulatory area preferred
  • Strong knowledge in the FDA, and rest of the world regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46 ; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Part 11; GMP, GLP, GCP, CMC, Compliance, FDAC Act, IND, CTD, NDA, PDUFA).
  • Knowledge of GMP and GCP regulations and clear understanding of the Medical Device product requirements
  • Experience with clinical data release operations
  • Ability to find creative solutions to issues impacting timelines and budgets
  • Working experience with CAPAs and internal audit systems
  • Detail & deadline oriented; well organized
  • Excellent verbal & written communication skills
  • Good interpersonal skills; ability to interact with staff on all levels
  • Strong organizational and demonstrated problemsolving capabilities
  • Ability to thrive in a busy environment and maintain a positive attitude under pressure
  • Works independently with mínimal supervision
  • Superior leadership, facilitation, and communication skills

Pay:
$135, $145,000.00 per year


Benefits:


  • 401(k)
  • 401(k)
matching

  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Paid time off
  • Parental leave
  • Tuition reimbursement

Schedule:

  • 8 hour shift

Application Question(s):

  • Will you now, or in the future, require sponsorship for employment visa status (e.g. H1B visa status)?

Education:


  • Bachelor's (preferred)

Experience:


  • QA/RA: 7 years (required)

Ability to Commute:

  • Watertown, MA required)

Work Location:
In person
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