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Deciphering FDA cosmetic regulations is a bit like solving a puzzle. There are clear directives guiding the manufacture and packaging of a cosmetic product, others to prevent misbranding, adulteration, or the use of certain banned substances. But deciding whether a product is a cosmetic or a drug — and which regulations apply to which product — can be like trying to fit jagged pieces together while blindfolded and with one hand tied behind your back.
Companies are implementing well-defined and standardized new product introduction processes that expedite product launches by aligning departments, tracking action items, and keeping the entire team adequately and accurately informed of project status and updates. However, following a complicated introduction process can be equally as frustrating, intimidating, and byzantine as launching without a formalized process. Lack of project ownership, disjointed or incomplete communication..........
Companies are implementing well-defined and standardized new product introduction processes that expedite product launches by aligning departments, tracking action items, and keeping the entire team adequately and accurately informed of project status and updates. However, following a complicated introduction process can be equally as frustrating, intimidating, and byzantine as launching without a formalized process.
Do you think there’s “nothing new under the sun” with regard to urinalysis? Until recently, that may have been the case. Urinalysis, the world’s oldest diagnostic test, was long regarded in the laboratory as a necessary, labor-intensive procedure which provided invaluable but limited information for clinicians. Now, however, urinalysis is changing, courtesy of a new generation of analyzers that integrate and automate its two primary functions: chemistry and microscopic particle analysis.
If you manufacture medical devices for sale in the European Union, you’ll have to show that they conform to the EU’s new Medical Device Regulation (MDR). How you demonstrate conformity depends on how big a risk your device presents to patients. For devices that pose the greatest risk you have to engage a Notified Body (NB), a third-party organization that assesses your device’s fulfillment of the EU’s requirements.
Strategic Copywriter and Marketing Content Consultant Initiative-taking, creative, and versatile strategic copywriter and marketing consultant specializing in the medical device, regulatory and life science industries. Experienced in developing and executing marketing messaging, segmentation, strategy, and collateral for multinational companies. Published author proficient in writing engaging blogs, long-form articles, and targeted social media posts.
Company: Leslie Williams Writes
I worked there from /2018 until now
Core responsibilities included: • Contributed to organizational goals by achieving $21M in annual revenue for urinalysis • Assessed market trends and future needs, appropriate market segmentation and competitive SWOT • Designing strategic marketing and product line business plans for all urinalysis products • Collaborating with technical and sales training to develop effective slide decks and other tools • Achieved 86% adoption rate for BeyondCare Quality MonitorSM within nine months of launch
Company: Sysmex America, Inc.
I worked there from 4/2012 until 8/2018
Core responsibilities included: • Establishing the editorial content calendar and strategy for all corporate social media accounts • Assisting the Director of Global Market Strategy and Development with daily marketing operations • Developing and posting daily content optimized to increase traffic • Creating website content and messaging for newly designed website • Collaborating with contracted design agency on new branding strategy and execution
Company: Blue Channel Media/MD Orthopaedics
I worked there from 11/2019 until 12/2022
Core responsibilities include: • Developing the tactical marketing and content strategies for the company • Drafting brand positioning, messaging and social media content strategy in alignment with corporate branding and strategic plan
Company: HPS Advise
I worked there from /2020 until /2021