Heidi Strunk, Rac Email & Phone Number

Whitestown, Indiana, Us

• Head of Quality and Regulatory, covering all US facilities• Determine and drive regulatory and quality strategy for business on global level • Manage staff of thirty, covering QC, QA, quality systems, compliance, and regulatory submissions, including 510(k)’s• Manage regulatory aspects of product approvals and sales into over 100 countries • Led successful warning letter remediation.• Provide expert guidance regarding quality system regulations and regulatory compliance• Led company to successful MDSAP, IVDR, and ISO 13485:2016 certification• Expertise includes compliance, quality systems, strategy, risk management, design controls, and software requirements• Frequent presenter at educational events sponsored by Indiana Medical Device Manufacturers Council

Whitestown, Indiana, Us

Indianapolis, In, Us

Served as resident medical device expert, working directly with clients on various projects. • Performed international quality system audits for compliance and inspectional preparedness against the ISO 13485 standard and the FDA and Canadian medical device regulations.• Partnered with clients to prepare and/or review regulatory submissions.• Provided a multitude of quality and regulatory services, depending upon the client’s needs. Services ranged from determining regulatory strategies for potential products, to leading quality system remediation activities and providing employee training.• Active member of IMDMC education committee, including speaking and presenting at public educational events.• Authored a whitepaper, “In Vitro Diagnostics – Clearing Up the Confusion”, which was published as the feature article in the January edition of the Regulatory Affairs Professional Society’s Focus magazine

Marlborough, Ma, Us

• Recruited for FDA remediation. Directed all quality and regulatory aspects in a hyper-growth company selling capital equipment, sterile disposable biopsy devices, sterile implantable products, and non-sterile accessories. Included quality system design, domestic and international regulatory affairs, quality control (QC), quality assurance (QA), complaint handling, medical device reporting, recalls, calibration and document control.• Increased regulatory compliance, and decreased the number of FDA 483 findings from nineteen to zero in less than two years.• Grew approved markets from two to twenty-four. • Created and implemented a program to recapture returned goods, resulting in $1.2 million annual savings.• Managed transition of product line transfers to both domestic and international manufacturing sites, and subsequent shutdown of local facility.• Spearheaded disaster recovery team after a fire in production clean room, resulting in resuming production in just seven days. • Led team to analyze historical test results and proposed decrease in testing, resulting in a two-week reduction in turnaround time, and annual savings of $1M less inventory carried, and >$100,000 in product costs alone.• Executed transition from a small startup company to a Fortune 500 public company, with no resulting loss of staff. • Implemented multiple IT systems platforms, including: Oracle enterprise management, Agile product data management and document control, and TrackWise system for complaints, MDRs, corrective and preventive actions (CAPAs), and calibration.

Westfield, Indiana, Us

Software company providing custom telematics solutions and advanced analytics to the heavy equipment industry. Recruited to develop and implement a quality system, preparatory to sale of company. • Created sustainable quality system, processes, and procedures at a scale appropriate to meet the requirements of a custom software house, without being overly burdensome.• Utilized knowledge of software and ISO requirements to ensure production-readiness.• Managed audits/interactions to instill confidence in purchaser, a major industry player.• Achieved successful first-time-pass audit result, with compliments from auditor.

Switzerland 🇨🇭 , Ch

• Six Sigma Black Belt. Identified and led process improvements throughout Centralized Diagnostics organization.• Drove improvement programs for progress, results, and business change. Defined project boundaries, led cross-functional teams, performed trouble-shooting for root cause analysis, analyzed data, managed expectations and resolved resistance. • Participated in extensive training in Six Sigma, LEAN manufacturing, facilitation, and conflict resolution

Switzerland 🇨🇭 , Ch

• Chief Quality Officer for Roche Applied Science (RAS) overseeing all aspects of US quality system, including identification of gaps (ISO 9001 and FDA’s QSReg). Frequently traveled to Germany, and attended global meetings as RAS representative.• Maintained ISO certification for entire division, both catalog sales and the custom-order business, including the Indianapolis and Berkeley, CA sites. • Launched analyte specific reagent in vitro diagnostic kit used for cystic fibrosis screening.• International representative for policy and systems development, quality and regulatory plans, import permits, and labeling.

Switzerland 🇨🇭 , Ch

Designed, implemented, and drove QSReg/GMP system design & ISO 9001:1994 program certification for division of 200+ people at two sites, including Commercial Operations side of business. Developed processes, systems, and documentation as required, ensuring compliance to regulatory standards.

Switzerland 🇨🇭 , Ch

Multiple positions over the course of this time period, beginning as a lab technician. Worked up to supervising the production cleanroom, then transferred to quality systems.