Senior Regulatory Affairs Specialist

2 months ago

Saint Paul, Minnesota, United States Abbott Full time

About the Role

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 compliance of our medical devices with regulatory requirements worldwide.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with global regulations and standards.
  • Provide regulatory input to product development and lifecycle planning to ensure compliance with regulatory requirements.
  • Assist in the preparation and submission of regulatory documents, including 510(k) and PMA submissions.
  • Monitor and analyze regulatory changes and updates to ensure compliance with evolving regulations.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development process.
  • Develop and maintain relationships with regulatory agencies and industry partners to stay informed about regulatory developments.
  • Provide regulatory guidance and support to internal stakeholders to ensure compliance with regulatory requirements.

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, preferably in regulatory affairs or a related field.
  • Strong knowledge of regulatory requirements and standards for medical devices.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Ability to analyze complex regulatory information and develop effective solutions.
  • Strong problem-solving skills and attention to detail.

Preferred Qualifications

  • Master's Degree in Regulatory Affairs or a related field.
  • 5+ years of experience in regulatory affairs or a related field.
  • Experience with 510(k) and PMA submissions.
  • Knowledge of international regulatory requirements and standards.
  • Certification in Regulatory Affairs, such as RAC from the Regulatory Affairs Professionals Society.

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