- Abbott (Sylmar, CA)
- …requirements + Review and approve advertising and promotional items to ensure regulatory compliance + Ensure external communications meet regulations + Develop, ... Abbott is a global healthcare leader that helps people live more... risks of division policies, processes, procedures + Provide regulatory input to product lifecycle planning +… more
- Edwards Lifesciences (Irvine, CA)
- …domestic and international product submissions + Full knowledge and understanding of global regulatory requirements for new products or product changes + ... and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide guidance on… more
- Abbott (San Diego, CA)
- … product concepts and recommend future strategies and actions. + Develop and update global regulatory strategies based on regulatory changes. + Conduct ... Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're...for product development and planning throughout the product lifecycle. + Analyze and compare regulatory … more
- Abbott (Alameda, CA)
- …charges. + Review and approve labeling to ensure compliance . + Represent regulatory affairs in product recall and recall communication process in APAC. + ... requirements + Review and approve advertising and promotional items to ensure regulatory compliance . **Required Qualifications** + Bachelor's Degree. + Minimum 5… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …inputs (including all documents required under risk files.) + Knowledge of global Regulatory Affairs requirements, regulations, and standards + Strong ... Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... or may oversee such preparation. **WHAT YOU'LL DO** **Strategic Planning:** + Provide regulatory input to product lifecycle planning. + Assist in the development… more
- Abbott (Alameda, CA)
- …Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory ... Abbott is a global healthcare leader that helps people live more... product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide… more
- Ascendis Pharma (Palo Alto, CA)
- …Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies with focus on America's and the clinical, and ... members and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk… more
- GRAIL (Menlo Park, CA)
- …labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international ... with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material… more
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