The Senior Regulatory Affairs Specialist is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies at the Abbott Molecular, Inc. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations.
Additional Main Responsibilities
Provides primary regulatory interface with operations and support programs.
Submits facility/product registrations, licenses, permits, and amendments as required.
This includes periodic renewals and revisions.
Assures that current products and manufacturing operations are in compliance with applicable regulations.
Implements the approval process for new products and product changes to assure timely market entry.
Provides a timely review of technical data, labeling, promotional material, and product documents.
Reviews, revises, and approves or rejects all product labels and/or labeling (e.g., operations, assay, procedures, manuals). Ensures regulatory compliance to preclude product recall.
Maintains current knowledge of FDA trends and expectations and evaluates promotional literature in accordance with these changing guidelines.
Provides leadership in developing strategies to deal with FDA law and regulations in order to achieve early market entry and cost effective operation of the business while maintaining regulatory compliance.
The Senior Regulatory Affairs Specialist position is accountable to the Regulatory Affairs Manager for achieving mutually agreed upon objectives in a timely manner.
The incumbent must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met to maintain division approval.
The incumbent must effectively communicate, prepare, and negotiate both internally with AMD personnel and externally with various regulatory agencies.
The incumbent must also properly interpret and apply regulatory requirements.
The position impacts the entire operation through GMP compliance requirements and activities such as label/labeling approval, and program compliance consistency.
Preferred Previous Skills – 1) Design control experience; 2) Device experience (2 years in industry); 3) RA experience is desirable; 4) Device Medical Writer with strong submission and design control experience.
Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
Bachelor’s degree in biology, chemistry, microbiology, immunology, or medical technology required. The incumbent needs a science background in order to review and understand Research and Development technical documents, labeling claims, and clinical data. RAPS Certification preferred. Five years experience in the health care industry, preferably in manufacturing or quality operations, and / or at least 2 years experience in regulatory affairs (preferably with in vitro diagnostics or medical devices).