Abbott Regulatory Affairs Job Opening – Apply Online
Abbott Regulatory Affairs Job Abbott Biotech Jobs 2020. Abbott invites postgraduate and undergraduate Biochemistry, Biology, Microbiology, Molecular, Cellular & Developmental Biology or Molecular Biology candidates for the post of the Regulatory. biology jobs 2020. Interested candidates may check all the details on the same below:
Job Title: REGULATORY AFFAIRS SPECIALIST – MEDICAL DEVICE / LABELING
Location: REGULATORY AFFAIRS UNITED STATES – CALIFORNIA – SANTA CLARA
MAIN PURPOSE OF ROLE:
Abbott Regulatory Affairs Job
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
MAIN RESPONSIBILITIES:
Abbott Regulatory Affairs Job
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Core job responsibilities for this function may include: Strategic Planning: · Assist in SOP development and review.
- Abbott Regulatory Affairs Job Provide regulatory input to product lifecycle planning.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk-benefit analysis for regulatory compliance pre-market:
- Monitor applications under regulatory review.
- Evaluate proposed pre-clinical, clinical and manufacturing changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities post-market:
- Maintain annual licenses, registrations, listings and patent information
- Assist compliance with product postmarketing approval requirements.
- Assist in the review of advertising and promotional items.
- Assess external communications relative to regulations.
- Review the regulatory aspects of contracts.
- Abbott Regulatory Affairs Job 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.
- Contribute to the development and functioning of the crisis/ issue management program.
- Abbott Regulatory Affairs Job Ensure product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications Job-specific responsibilities may include (choose applicable areas and expand as appropriate). ·.
- Medical writing · Advertising and promotion · Labeling · Controlled substances (e.g.
DEA) · Restricted substances (e.g. - REACH) · Compendial/standards · Import/export · Country-specific regulatory support.
REQUIRED QUALIFICATIONS:
Abbott Regulatory Affairs Job
- 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. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 2-3 years of experience in a regulated industry (e.g., medical products, nutritional). The regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Note: Higher education may compensate for years of experience. Background / Skills / Knowledge Regulatory Knowledge of (as applicable): ·
Communication Skills or Ability to: ·
Abbott Regulatory Affairs Job
- Communicate effectively verbally and in writing ·
- Communicate with diverse audiences and personnel ·
- Write and edit technical documents ·
- Work with cross-functional teams ·
- Work with people from various disciplines and cultures ·
- Write and edit technical documents ·
- Negotiate internally Cognitive Skills or Ability to: ·
- Pay strong attention to detail ·
- Abbott Regulatory Affairs Job Manage projects ·
- Create project plans and timelines ·
- Think analytically and critically ·
- Organize and track complex information ·
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions ·
- Has a sound knowledge of a variety of alternatives and their impact on the business ·
- Apply business and regulatory ethical standards
