November 15, 2021

Manager, Regulatory Affairs

Pasadena
Posted 3 weeks ago

Innova Medical Group, Inc. delivers better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious diseases. In response to the global pandemic, Innova developed an end-to-end ecosystem of rapid diagnostic and screening tests, along with digital reporting and tracing applications to help organizations manage the COVID-19 crisis. In 2020, Innova delivered more than 220+ million COVID-19 test kits to over 20 countries around the globe, including the United Kingdom, Hungary, Singapore, United Arab Emirates, and Myanmar. As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova​ has improved lives with testing, monitoring, and implementing medical care. Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.

Job Description

Manager Regulatory Affairs is responsible for product registrations in JAPAC (or EMEA or Americas) related to the design, manufacture, and sale of medical device and in-vitro diagnostic products. The position is responsible for obtaining and maintaining regulatory approvals in keeping with business objectives.

 

Responsibilities

  • Assist in obtaining and maintaining all necessary regulatory registrations, approvals and certifications as required to facilitate the sale of products in JAPAC (or EMEA or Americas) and other international markets as determined by business objectives.
  • Specific knowledge of IVD products
  • Experience with both IVD prodcuts in JAPAC (or EMEA or Americas)
  • Oversee Compliance and Ethics Program.
  • Participate in product development activities representing local regulatory standards are understood and implemented to support regulatory submissions.
  • Manage contracted consultants, as required.
  • Manage activities per approved budget and annual operating plan.
  • Comply with all company policies and procedures.
  • Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

  • Must have knowledge of local registration and submission requirements Must have experience with local product submissions and market approvals.
  • Excellent management skills, both of individuals as well as projects.
  • Must have strong work ethic.
  • Excellent oral and written communication skills required.
  • Attention to detail is required.
  • Effective conflict resolution.
  • Analytical & problem-solving skills & ability to multitask.
  • Solutions-oriented problem solver.
  • Excellent planning, communication and organizational skills.
  • Ability to effectively interface with different departments within the company.
  • Strong project management and organizational skills.
  • Business acumen – able to show flexibility in approach depending on the business need.
  • Ability to work cross functionally to complete projects in on time.

Qualifications

  • Bachelor’s degree in Engineering, Biological Science or related technical discipline, required.
  • MBA or advanced degree in management or professional certification in manufacturing disciplines, preferred.
  • 5+ years’ experience in Regulatory Affairs for an in-vitro diagnostic company, required.
  • Regulatory background with local market experience with Medical and In-vitro Diagnostic devices and assigned geography.
  • Advanced knowledge/proficiency in Microsoft Office, required.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Legal authorization to work in the United States is required.

This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.

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