Compliance Business Oversight Manager managing compliance risk at TD Bank. Overseeing Affiliate Transactions Data Review and providing insights on regulatory compliance.
About the role
- Senior Regulatory Affairs Manager at Abbott managing compliance and regulatory strategies for medical products. Leading project management and regulatory submissions in the healthcare sector.
Responsibilities
- Provide regulatory affairs project management for various areas, to include 510(k), CLIA Waiver, label/advertising/promotional review, and other regulatory compliance activities.
- In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets.
- Coordinate preparation of well organized, complete and scientifically sound regulatory submissions.
- Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
- Exercise judgement within generally defined practices and departmental standard operating procedures.
- Develop and maintain strong and effective relations with internal/external personnel.
- Interacts with regulatory agency to expedite approval of pending registration.
- Serves as regulatory liaison throughout product lifecycle.
- Advises development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations and interpretations.
- Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale.
Requirements
- Bachelor's Degree Preferably in scientific or engineering related disciplines or an equivalent combination of education and work experience
- At least 6 years or more of experience in a similar role in similar organization.
- Advanced degree or additional professional training in regulatory affairs (RA) desired.
- At least 3 years of experience with molecular and lateral flow assays
- Must have well developed written, oral, interpersonal and negotiation skills.
- Leadership competency including organizational development and project management skills.
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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