- Balchem (Faribault, MN)
- …integrate quality systems across sites. Knowledge & Experience: + Operated in an FDA regulated environment, ideally food or dietary supplement + Assess and mitigate ... experience in food, supplement, or related industry, including management. + Familiarity with FDA , HACCP, SQF, and industry best practices. + Ability to lift 50… more
- MPE Inc. (Sturtevant, WI)
- …activities in metal fabrication + Ensure all manufacturing processes comply with FDA , ISO 13485, and other relevant medical device industry regulations. + Monitor ... + Strong knowledge of fabrication techniques and processes + Familiarity with FDA , ISO 13485, and other relevant regulatory standards. + Proven ability to… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... equipment in pharmaceutical or biopharmaceutical industry. + Strong knowledge of cGMP, FDA , EMA, and ICH guidelines. + Experience with bioreactors, fermenters, cell… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... Multiple experience in preparing and interacting with multiple regulatory agencies including FDA , EMA, and others + Multiple NDA/MAA submission experience + Proven… more
- J&J Family of Companies (Danvers, MA)
- …Quality & Regulatory Compliance** + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as ... operations within medical devices or complex product environments. + Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485. + Experience with design controls,… more
- AbbVie (Mettawa, IL)
- …accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and ... cosmetic Act. + Development and guides implementation strategies for promotional activities + Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas. + Ensure departmental training and compliance with… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... testing, and registration and annual stability programs + Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical… more
- Genentech (South San Francisco, CA)
- …and legal direction on, healthcare fraud and abuse laws, pricing, FDA labeling and promotional matters, cGMP compliance, products liability, antitrust, privacy ... and partnerships; + Advising regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; + Counseling… more
- Abbott (Alameda, CA)
- …+ Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... software validation experience in a medical device company + Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304 **Preferred Qualifications** + Knowledge of Jira,… more
- Beth Israel Lahey Health (Burlington, MA)
- …medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. + ... + Implements all study protocols in accordance with research SOPs, FDA , OHRP, and GCP regulations. + Immediately develops coordinator/sponsor relationship. +… more