Danielle Lindner Email & Phone Number

Winsford, Cheshire, Gb

• Lead interactions with FDA for pre-market notifications. -Author Q-Submissions, Teleconference Presentations, & Meeting Minutes for FDA. -Coordinate responses to Substantive Interactions for active 510(k). •Support cross-functional teams. -Review and edit planned MDR submissions. -Provide technical writing and project management support for MDR deficiencies.-Act as US specific subject matter expert for review of promotional materials & change control. •Advise the business unit and project teams on regulatory strategies, submissions, and approval pathways for the US Market. Apply regulatory knowledge of competitor products, strategies, and market to help find opportunities and/or resolve potential challenges. •Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.

Hillsboro, Oregon, Us

Maintain Technical Files in accordance with the European Medical Device Directives.Author and Editor of Clinical Evaluation Reports (CERs) in accordance with MEDDEV 2.7.1 Rev. 4

Hillsboro, Oregon, Us

Management representative for the quality system.-Maintains compliance to FDA's QSR requirements.-Oversee quality and inspection operations.-Coordinate the inspection and quality duties throughout company.-Assure ongoing compliance to the Quality Assurance Manual.-Support and participate in the quality objectives within the company.-Supervise Quality personnel.-Qualifies and monitors vendors.-Reviews, approves, verifies, and participates in Corrective Action.

Hillsboro, Oregon, Us

•Assist in compliance of quality system regulations and adherence to ISO Standards.- These regulations include (but are not limited to) 21 CFR 820, ISO 13485, and MDD 93/42/EEC.- Adhere to overall control and maintenance of quality system documentation, RMRs, CERs, and CAPAs.•Provide technical interface between international regulatory reviewers and distributor questions to provide timely and accurate response while maintaining confidentiality of product and company information.-Coordinate and track the legalization of regulatory documents (such as LOAs and CFGs)•Assess the regulatory impacts of proposed engineering change requests to orthopedic implants and instruments.•Collaborate with cross functional teams to provide regulatory input into projects and line extensions.

New Brunswick, Nj, Us

• Author and prepare the timely submission for regulatory applications, renewals, and maintenance (e.g. PMA 30 Day Notice, PMA annual reports, and PMA post approval study reports).• Interface with reviewers through written and oral communications and assist in correspondence with regulators and notified body experts.• Collaborate with R&D to provide regulatory input into NPD project teams.• Assess the regulatory functional impacts of proposed changes to product and process.• Serve as the regulatory representative on cross-functional teams including, but not limited to quality, manufacturing, clinical, medical affairs, marketing, and post-market surveillance. • Earned an Encore Award for "persistence and diligence in getting approval [...] in record time and at a savings of over $40,000 to the company".

Paramus, Nj, Us

•Assist in compliance of quality system regulations and adherence to ISO Standards in respect to medical devices manufactured utilizing tissues of animal origins.-These regulations include (but are not limited to) 21 CFR 820, ISO 13485, and MDD 93/42/EEC.-Preparation and/or maintenance of reports such as shelf life, design FMEA risk tables, animal origin risk analyses, clinical evaluation, zoonosis, etc. -Adhere to overall control and maintenance of quality system documentation, SOPs, and training records.• Author technical documents to obtain clearance/approval and bring new or modified products to domestic and international markets.-These submissions include (but are not limited to) 510ks, design examinations for CE marking, Health Canada medical device licence, TGA conformity assessments, certificate renewals, and change notifications.- Provide technical interface between international regulatory reviewers and distributor questions to provide timely and accurate response while maintaining confidentiality of product and company information.-Coordinate and track the legalization of regulatory documents (such as LOAs, POAs, DOFMs, CFGs, FSCs, EIRs, and DOCs) •Design, review, and approve new labeling according to in-house procedures with HIBCC and/or GS1 bar codes to conform to Unique Device Identification (UDI) system requirements.-These labeling revisions adhere to good documentation practices and may include (but are not limited to) updates engineering change orders, material specifications, SOPs.

Pine Brook, New Jersey, Us

•Support the analytical R&D team. -Purchasing responsibilities include: obtaining and negotiating price quotes, purchasing orders, invoicing, and building a relationship with various vendor contracts. -Draft and Review R&D protocols and methods (Assay/RC, Dissolution, Content Uniformity, and Residual Solvents). -Organize and maintain meticulous data records, such as Certificates of Analysis and Material Safety Data Sheets (MSDS), for all incoming and outgoing samples. -Compare vendor and in-house methods to USP and NF methods.• Track and uphold repair schedules for instruments such as HPLC, GC, Auto Samplers, and various other wet analytical devices. • Received Training on QUMAS, a quality management and compliance software, to assist the R&D team transition from old methods to new.

Woodcliff Lake, Nj, Us

•Coordinate with contract research organizations. -Review laboratory activities in compliance with ICH, OECD, and GLPs. -Monitor studies and evaluate reports for congruence with SOPs. -Collaborate with the study director and laboratory staff for publications and presentation of results.•Assist in the evaluation of reproductive, developmental, and repeated dose endpoints. -Draft tables, figures, and dossiers for use by industry experts (i.e. REACH). -Compile chemical analogues by reviewing RIFM’s database and common literature such as JECFA, WHO, SIDs, NTP, and FEMA summaries.

Woodcliff Lake, Nj, Us

*Manage, edit, and write while maintaining accuracy and timeliness for multiple projects.*Compile and review a literature search from company documentation, common literature and online databases.*Attend professional meetings and educational lectures to present company’s research.*Interact with freelance consultants, RIFM’s expert panel, and respected individuals within the fragrance industry.*Organize and coordinate the chemical structure-activity groups of fragrances for review as toxicological safety assessments, ultimately leading to over 100 peer reviewed publications within the Journal of Food and Chemical Toxicology.

Riverdale, Ny, Us

Evaluated spatial characteristics of perennial vegetation in the Sonoran Desert.2006 Excellent Written Paper at Eastern Colleges Science Conference

*Assisted the veterinarian with physical examinations to determine the nature of the illness or injury. *Tasks in patient care included: recording temperature; ear flushes; feedings and giving medication. *Maintained the treatment records and inventory of all pharmaceuticals, equipment and supplies. *Technical skills include: performing skin scrapings; taking and processing radiographs; and performing routine lab tests in microbiology and urinalysis.

*Presented live animal demonstrations in zoo amphitheater or discovery center for the general public.*Designed and led summer camp programs and recreation groups (including birthday parties and/or girl scout events).*Assisted in the enrichment and socialization of the education department's exotic animals.

Bachelor Of Science, Biology

Education record