Regulatory affairs leadership position within Abbott Diagnostics Hematology business unit. Responsible for global product registrations and labeling of Hematology IVD products. Lead resources within Hematology and partner with global affiliates to achieve registration and labeling objectives. Lead a team of 2-4 in Regulatory affairs. Reports to the Director Regulatory Affairs for Abbott Hematology.
The Associate Director has business unit-wide influence, responsibility and functions as an internal expert resource. The individual will be actively called upon to provide regulatory guidance to business unit leadership and project teams. In addition, this role is responsible to:
- Develop and implement regulatory strategies to achieve global regulatory approval timelines for new products and feature enhancements
- Maintain business continuity through insuring the continued registration of on market products
- Lead product labeling for all new and on market products, insuring compliance with regulations
- Represent regulatory affairs as part of resolving on market product issues including complaints, CAPA, MDRs and field actions. Provide regulatory input during audits and in adverse eventreporting
- Provide input and technical guidance on regulatory requirements to development teams. Negotiate with regulatory authorities as part of the pre-market development process and during submissions
- Oversee regulatory aspects of business relationships to ensure compliance
- Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture
- Coach, develop and motivate the team to build a sustainable pipeline of leaders for the organization. Act as a model leader in the organization.
- Bachelor's degree (or equivalent); Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 10 years’ experience in Medical Device Class II industry Regulatory Affairs. IVD experience is preferred.
- Track record of leadership of global submissions. Has led registration of new system through FDA 510k & submission & CE declaration
- Experience directly working with the FDA to through the submission process and to resolve on market issues
- 3 years direct people management experience
- Bachelors degree. Advanced technical education preferred