Careers – Regulatory Affairs Specialist
Essential Functions & Responsibilities
(Other Functions May Be Assigned)
- Ensures that the necessary product approvals (CE marking, 510(k)’s, Health Canada) are obtained and maintained based on planned markets.
- Develops plans and procedures to achieve compliance to EU Medical Device Regulation.
- Communicates with regulatory agencies on behalf of the company in relation to quality or regulatory matters.
- Liaises with Notified Bodies and/or Competent Authorities/FDA regarding regulatory and vigilance issues.
- Maintains knowledge of relevant advances for the industry with regard to US and International standards and norms.
- Provides regulatory information and risk-based assessments for the design, service and other technical functions in the company. Review quality related documentation for compliance with the company’s requirements and regulatory requirements.
- Supports Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product.
- Oversees, maintains, and creates Quality System documentation and regulatory files.
- Participates in decision-making team relating to Medical Device Vigilance, MDR’s, product recalls and issuance of Advisory Notices, if required.
- Reviews and approves validation activities.
Qualifications / Experience Requirements
- Minimum of seven to ten years regulatory affairs experience with emphasis in the medical device industry.
- Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device Regulations. Other countries may become necessary.
- Hands on experience with product documentation and the preparation of 510(k)s, and international dossiers/technical files.
- Experience with devices containing both hardware and software components.
- Excellent communication, interpersonal, time management, and leadership skills.
- Must have a “how can we get it done,” rather than a “why we can’t do it” approach.
- We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
- Appropriate certifications preferred.
- Required education: Bachelor's in Engineering.
If you are interested in this position at Exergen Corporation, please fill out the form below and we'll get back to you.
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, non-invasive 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 Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.