Abbott Biology Job Opening 2020 – Candidates Apply Online
Abbott Biology Job Opening Abbott Regulatory Affairs Job Abbott Biotech Jobs 2020. Abbott invites postgraduate and undergraduate Biology, Microbiology, Molecular, Cellular & Developmental Biology or Molecular Biology candidates for the post of the Regulatory. biology jobs in 2020. Interested candidates may check all the details on the same below:
Job Title: SENIOR REGULATORY AFFAIRS SPECIALIST – IMMUNOASSAYS/CLINICAL CHEMISTRY
Location: REGULATORY AFFAIRS UNITED STATES – ILLINOIS – ABBOTT PARK
RESPONSIBILITIES:
Abbott Biology Job Opening
- As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
- Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to determine regulatory strategies for approval/clearance/registration worldwide.
- The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
- Assist in SOP development and review. Provide regulatory input to product lifecycle planning.
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Determine trade issues to anticipate regulatory obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk-benefit analysis for regulatory compliance.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Abbott Biology Job Opening Compile, prepare, review and submit a regulatory submission to authorities.
- Monitor the impact of changing regulations on submission strategies.
- Monitor applications under regulatory review.
- Monitor and submit applicable reports to regulatory authorities.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Assess external communications relative to regulations.
- Review regulatory aspects of contracts.
- Abbott Biology Job Opening Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Analyze the input of cumulative product changes to current product submissions.
- Contribute to the development and functioning of the crisis/ issue management program.
- Ensure product safety issues and product associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
ACCOUNTABILITY:
Abbott Biology Job Opening
- Abbott Biology Job Opening Individuals execute and manage technical and scientific regulatory activities.
- Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
- Properly interpret and apply regulatory requirements.
- Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.
- Work is reviewed upon completion for adequacy in meeting objectives.
- The individual is recognized as an expert in workgroup.
- Understands the business environment and relates extensive knowledge of internal and external activities to trends.
- Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
- Participates in the development of others by facilitating training and providing feedback and guidance.
- May lead a cross-functional project team.
- Provides technical leadership to business units.
- Abbott Biology Job Opening Acts as a mentor to less experienced staff.
- Exercises judgment independently.
- Plans and organizes project assignments of substantial variety and complexity.
- Initiates or maintains a schedule for projects and project milestones.
- Establishes priorities of individual or project assignments.
- Selects methods and techniques to lead a project to completion.
- Erroneous decisions or recommendations would typically result in failure to achieve organizational objective.
QUALIFICATIONS:
Abbott Biology Job Opening
- Bachelor’s degree (or equivalent)
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritional).
Note: Higher education may compensate for years of experience.
PREFERRED QUALIFICATIONS:
Abbott Biology Job Opening
- Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), or medical fields
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 2-3 years of experience in regulatory but may consider quality assurance, research and development/support, scientific affairs, operations, or related technical area.
- 2+ years of experience interpreting and applying U.S. FDA regulations
