Sr. Regulatory Compliance Specialist
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
PRIMARY JOB FUNCTION:
As a key member of the Regulatory Compliance team, ensure that AV sites are in compliance with applicable Corporate, FDA, and international regulatory requirements.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Manage projects related to integration of U.S. and international regulations and/or Abbott policies into the site and divisional Quality System. May necessitate leading and/or working on project teams consisting of AV personnel from other departments and/or sites, including international sites and affiliate offices.
2. Develop and provide training on Quality System procedures as needed.
3. Direct preparatory and follow-up activities related to external quality system audits, including scheduling, hosting duties or other direct auditor interface, and compilation of Proof Books.
4. Review the task completion as part of the audit findings and approve it in CATSWEB and close out the audit finding.
5. Conduct and document Corrective and Preventive Action (CAPA) investigations for any audit findings in area of responsibility.
6. Coordinate site Management Review meetings, including preparation of presentation materials and documentation of meeting minutes.
7. Manage or provide support for other site and divisional Quality Systems projects as needed.
POSITION ACCOUNTABILITY / SCOPE
Describe the nature and magnitude of the impact of this position’s decisions and/or actions on the division or function. Cite impact in terms of sales volume, capital expense, project scope, throughput, etc. where possible.
Reliable attendance is required for this position. Must be able to function independently in a leadership role, but also able to recognize when management consultation or approval is required.
· 4 years of experience in a medical device or other FDA-regulated industry; Quality Assurance experience preferred
· Knowledge of medical device Quality System Regulations (21 CFR 820, ISO 9001/13485)
· Familiarity with MS Office applications – Outlook, Word, Excel, Power Point
· Ability to conduct internet research
· Ability to work in team environment
· Excellent written and verbal communication skills (writing samples may be requested)
Bachelor's Degree, plus 6+ years of related work experience with a strong understanding of specified functional area, or equivalent in Life Science or related discipline or equivalent work experience.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Yes, 25 % of the Time