Director Regulatory and Clinical Affairs

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.

Abbott Molecular Division Management Representative for Quality System global regulations.

Primary responsibility for compliance activities and operates as primary interface with regulatory agencies that enforce laws applicable to development, manufacturing, sales and distribution of all Molecular products. Identifies key regulatory decision makers and develops/maintains channels of communication through open professional relationships. Identifies and ensures availability and development of necessary staffing levels. Manages the registration of new products and changes to current products with the appropriate country regulatory bodies. Develops regulatory strategy to achieve business unit LRP while ensuring the Molecular business is in compliance with global regulatory agencies.

Responsible for implementing and maintaining the effectiveness of the quality system.
1. Plan, organize, guide and finalize approval of all documents submitted to all regulatory agencies with jurisdiction over all Molecular products in the US and abroad, including FDA and comparable state and local agencies.
2. Responsible for establishing, implementing and maintaining policies, practices, and systems at the site to meet all Molecular requirements and applicable regulations. Ensures consistent levels of compliance throughout the development, manufacturing and distribution of all Molecular products with a goal to minimize disruptive business issues (product recalls, product approval delays). Will guide and direct others for adherence with these systems, but holds primary responsibility for compliance.
3. Manage the review of and final approval process of all product advertising and labeling to determine compliance with government regulations and conformance with Molecular /Abbott standards.
4. Ensures that new products are registered with the applicable regulatory agencies in a timely manner, that registration packages are complete and that additional agency inquiries are answered in a timely manner. Also ensures that product changes requiring notification are processed accordingly.
5. Manages the research, interpretation, and distribution of key information on government regulations and the preparation/interpretation of comments on proposed legislation and regulations affecting medical device/diagnostics manufacturers. Develop and recommends policy with regard to medical device/diagnostics regulatory matters to Molecular senior management team.
6. Develop and maintain continuing education program on regulatory/clinical activities and new regulations to aid in organizational understanding and compliance with government standards. Review and monitor practices to Molecular and corporate regulatory policy to ensure compliance.
7. Quality System Management Representative. Interfaces with FDA inspectors, ISO-9000 and vendor/partner auditors, directing external audit activities. Initiates appropriate and effective corrective / preventive actions and generates responses to FDA Form 483s, ISO-9000 surveillance audits and other external quality system consultant audits.

Qualifications
Minimum six years of management experience in Regulatory Affairs and Clinical Affairs with FDA and ROW submission experience and experience in coordinating multi-center clinical trials.

Demonstrated ability to work in a multidisciplinary environment and adapt to a variety of projects/business circumstances.
Demonstrated ability to manage multiple projects, actively take on additional responsibility
Demonstrated ability to develop innovative solutions, while maintaining compliance with global regulations.
Demonstrated team building abilities, ability to develop an open and sharing information environment where appropriate.
Demonstrated leadership ability in Regulatory Affairs and Clinical Affairs.
Knowledge of global diagnostics regulations.
Knowledge and experience of working in a GMP environment and the impact of regulatory decisions on the diagnostic business.
Demonstrated ability to set project strategy considering technical, regulatory, and clinical project components and execute project to completion in a timely fashion.
Excellent communication/negotiation (oral and written) and interpersonal skills. Ability to articulate a clear regulatory affairs and clinical affairs positions while maintaining a positive team dynamic
M.S. degree in Life Sciences or equivalent



Abbott welcomes and encourages diversity in our workforce. EEO/AA

To apply for this position, click here.

To learn more about Abbott and view other opportunities, click here.