Senior Regulatory Affairs Specialist
4 weeks ago
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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