Current jobs related to Regulatory Affairs Specialist - Brea, California - enVista

  • Complaints Resolution Specialist

    1 month ago

    Brea, California, United States ProKatchers LLC Full time

    Job Title : Complaints Resolution SpecialistJob Summary:ProKatchers LLC seeks a skilled Complaints Resolution Specialist to coordinate complaint management activities and customer feedback failure investigations.Key Responsibilities:Review and implement product, project, and program quality activities to ensure compliance with regulatory...

  • Paralegal Specialist

    1 month ago

    Brea, California, United States Softpath System Full time

    Job Title: Paralegal Specialist Job Summary: We are seeking a highly skilled Paralegal Specialist to join our team at Softpath System, LLC. The successful candidate will provide support to our commercial sales and service teams, ensuring compliance with legal requirements and regulations. This is a unique opportunity to work with a dynamic team and...

  • Rehabilitation Therapist Specialist

    7 days ago

    Brea, California, United States Lifepoint Health Full time

    Lifepoint Health is a leading provider of acute inpatient rehabilitation services with more than 300 hospital-based rehabilitation units, medical/surgical and outpatient therapy settings across the country.About the RoleWe are seeking a skilled Speech Language Pathologist to join our team in Brea, California. The successful candidate will have the...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Brea, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    brea, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    brea, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Brea, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Brea, CA, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Marketing Specialist

    1 month ago

    brea, United States Samyang America, Inc. Full time

    Responsibilities Develop and execute product strategies to drive growth and meet business objectives.Conduct market research to identify trends, customer needs, and competitive products.Collaborate with cross-functional teams, including sales, PR, RA & QC, and SCM to ensure successful product launches and ongoing product management.Define and prioritize...

  • Marketing Specialist

    2 months ago

    Brea, United States Samyang America, Inc. Full time

    Responsibilities Develop and execute product strategies to drive growth and meet business objectives.Conduct market research to identify trends, customer needs, and competitive products.Collaborate with cross-functional teams, including sales, PR, RA & QC, and SCM to ensure successful product launches and ongoing product management.Define and prioritize...

  • Marketing Specialist

    3 weeks ago

    Brea, CA, United States Samyang America, Inc. Full time

    Responsibilities Develop and execute product strategies to drive growth and meet business objectives.Conduct market research to identify trends, customer needs, and competitive products.Collaborate with cross-functional teams, including sales, PR, RA & QC, and SCM to ensure successful product launches and ongoing product management.Define and prioritize...

Regulatory Affairs Specialist

1 month ago

Brea, California, United States enVista Full time
Job Title: Regulatory Affairs Specialist

Envista is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.

Key Responsibilities:
  • Develop and execute regulatory strategies for new and existing products
  • Prepare and maintain EU MDR technical files, Australian and New Zealand registrations, and FDA device listings
  • Conduct regulatory assessments for new product development and sustaining activities
  • Review and redline product labels and IFUs to meet global regulatory requirements
  • Ensure label conformity to global UDI requirements and submit/maintain UDI databases
  • Develop and generate departmental SOPs
  • Participate in audits and inspections of the company and its Quality Systems
  • Prepare monthly reports on status of current issues to the Manager of Regulatory Affairs
Requirements:
  • Bachelor's degree from a four-year college or university in a related field plus 2 years of relevant regulatory affairs experience required
  • OR High school diploma or equivalent AND 4 years of relevant regulatory affairs work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field
  • Ability to understand technical product information
  • Advanced degree or RAC certification preferred
  • Experience with Domestic submissions: US & Canada
  • Demonstrated international submissions experience (i.e., Saudia Arabia, APAC, LATAM, EU, Health Canada Technical files a plus)
Preferred Skills:
  • EU MDR/MDD or international submissions highly preferred
  • Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision
  • RA Project exposure working with cross functional teams
  • Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems
  • Enthusiastic self-starter with excellent verbal, written, and interpersonal skills
  • Highly organized, detail-oriented mindset and ability to be flexible and multi-task in a dynamically changing environment

Envista is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.