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Regulatory Affairs Specialist II
2 months ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
Key Responsibilities- Assist in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
- Create, review and approve engineering changes.
- Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
- Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards.
- Maintain pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current and up-to-date.
- Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Interface directly with FDA and other regulatory agencies as directed.
- Review protocols and reports to support regulatory submissions.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Bachelor's degree (or equivalent)
- 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Proficient with MS Office suite (Word, Excel, Outlook).
Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan and tuition reimbursement. If you're passionate about making a difference in people's lives, we encourage you to apply for this exciting opportunity.
