IVDR Program Manager
00000, IL 00000 US
- Provide Regulatory input to Design Plan cross functional teams: evaluate proposed changes for regulatory impact.
- Review and approve study protocols and records that will from part of Regulatory submissions.
- Work with the Medical Writing group in coordinating activities related to the preparation and compilation of data and information into a comprehensive package for regulatory submissions, ensuring tasks are completed on time.
- Issue Notifications of Change to Notified Body and / or country affiliates as appropriate.
- Coordinate with manufacturing sites, third party manufacturers and countries to ensure all necessary documentation is provided to facilitate timely completion of Regulatory submissions & acquisition of approvals.
- Real time tracking of submission and approvals: monitor applications under regulatory review and communicate application progress to internal stakeholders.
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities in a timely manner
- Ensure compliance with product post? marketing approval requirements.
- Ensure external communications meet regulations.
- Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation, and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Other duties as assigned, according to the changing needs of the business.
Education & Experience
- Bachelor's degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
- 5 years’ experience in a regulated industry (e.g. medical products) would be an advantage
- Minimum of 3 years’ experience in Regulatory Affairs.
- Experience with EU and other international medical device regulations and submissions.
- Experience working in a broader enterprise/cross?division business unit model preferred.
- Certification in Regulatory Affairs preferred.
- Ability to work in a matrixed and geographically diverse business environment with people from various disciplines and cultures
- Ability to work within a team and as an individual contributor in a fast paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Possess good written and oral communication skills.
- Strong organizational and follow up skills, attention to detail, excellent interpersonal skills to deal with multiple business
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
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