Titre du poste ou emplacement

Regulatory Affairs Intern

Communications and Power Ind. Canada Inc - 18 emplois
Georgetown, ON
Posté hier
Détails de l'emploi :
Temps plein
Expérimenté

Shaping the future through innovation and discovery!

With a history spanning more than seven decades, Communications & Power Industries' thousands of products have impacted people's lives in numerous unseen ways every day. Our highly engineered products serve as the backbone of modern-day commercial and military communications systems, assist in diagnosing medical conditions, empower scientific discoveries and space exploration, and much more.

We are actively seeking applicants for our Internship Program. Our interns will work alongside out multi-disciplined team on real projects.

Position Description:

The Regulatory Affairs Intern supports the Regulatory Affairs team by performing various regulatory activities related to the design, development, testing, manufacturing, and market authorization of medical devices. CPI's Georgetown Regulatory Affairs team ensures products comply with applicable regulations and standards.

Essential Duties and Responsibilities:

  • Assist with the development of regulatory submission documents and other quality assurance activities, as required.
  • Ensure all new submissions are filed and updated regularly in the Technical File for each product, as appropriate.
  • Maintain and update the technical file documentation for defense and commercial products.
  • Track the Engineering Change Order (ECO) action items, closeouts, and filings to perform risk assessment.
  • Assist with the revision of documents and records related to regulatory affairs. Support test activities.
  • Assist with developing and maintaining a regulatory submission tracking system for all products.
  • Assist with developing and maintaining a SharePoint workspace for the department related to regulatory activities and records.

Position Requirements:

  • Currently pursuing a bachelor's degree in engineering, science, or technology.
  • Strong interpersonal skills and ability to work with colleagues and cross-functional teams in a professional and organized manner.
  • Competence in operating computing hardware and standard software.
  • Able to work in a dynamic and fast-paced environment.
  • Strong communication and interpersonal skills.

Preferred Qualifications:

Familiarity with the following Regulations/Standards:

  • ISO 13485
  • ISO 9001
  • MDSAP
  • EU MDR 2017/745
  • UK MDR 2002

Security

  • Must meet all CGP and ITAR requirements

WHAT WE OFFER:
Whether you are a seasoned professional or just embarking on your career, CPI is an ideal place to expand your knowledge and expertise. We cultivate a healthy, dynamic, and team-oriented environment that empowers our employees to develop, create and deliver innovative, reliable technology solutions to power, connect, protect, and support a better tomorrow.


WHO WE ARE:

We value the unique and diverse skills, qualities, and backgrounds that each employee brings to CPI, and we respect each employee as an integral member of our growing team. CPI is committed to providing equal employment opportunities for all current and prospective employees, as well as to promoting a culture of inclusion and respect for everyone. We celebrate the innovation that diversity creates in the work environment, and we recognize that each employee brings their own unique capabilities, experiences, and perspectives to the organization. It is this variety that adds value to our teams, as well as to our stakeholders. We welcome and encourage applicants to reach their full potential with us.

CPI is proud to be an Equal Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability or other applicable legally protected characteristics.

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