Senior Regulatory Affairs Specialist

4 weeks ago


Saint Paul, Minnesota, United States Abbott Full time

The Opportunity

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott. This individual will play a critical role in ensuring the regulatory compliance of our medical products worldwide.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with global regulations.
  • Provide regulatory input to product lifecycle planning and ensure that all products meet regulatory requirements.
  • Collaborate with cross-functional teams to identify and mitigate regulatory risks.
  • Prepare and submit regulatory documents, including 510(k) and PMA submissions.
  • Monitor and analyze regulatory trends and developments to ensure compliance with changing regulations.
  • Develop and maintain relationships with regulatory agencies and industry partners.
  • Provide regulatory guidance and support to internal stakeholders.

Requirements

  • Bachelor's Degree in a related field, such as Regulatory Affairs, Law, or Life Sciences.
  • 3-4 years of experience in a regulated industry, with a focus on regulatory affairs.
  • Strong knowledge of global regulations, including FDA and EU regulations.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

Preferred Qualifications

  • Master's Degree in Regulatory Affairs or a related field.
  • 5+ years of experience in regulatory affairs, with a focus on medical devices.
  • Experience with 510(k) and PMA submissions.
  • Certification in Regulatory Affairs, such as RAC.


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