Frederic Testa Email & Phone Number

Watford, Hertfordshire, Gb

• Regulatory Integration lead for the Integra Extremity Reconstruction portfolio which was purchased by Smith and Nephew from Integra LifeSciences. Facilitated conflict resolution with Integra utilizing past relationships and social intelligence. Accomplishments included:o Transitioned Austin, TX and Lyon, France sites to Smith and Nephew Regulatory processes and procedures.o Provided strategic, regulatory direction in the assessment of the Extremity Reconstruction portfolio, partnering with Marketing in making commercial decisions to maintain, cancel, or obtain new product registrations worldwide to align with the company’s global commercial strategy.o Lead the Regulatory workstream to close the Lyon, France site for S-N including the transfer of regulatory responsibilities to Austin, TX site.• Directed and was responsible for all FDA and Notified Body Audits. Functioned as front room lead for legal manufacturer Audits including strategic review of responses during the audit process. No Major findings were received during these Audits.• Directed teams of managers and specialists to execute complex global regulatory strategies for new product development, sustaining activities, and international market expansion initiatives for Orthopedic implants including US FDA, EU MDR, Health Canada, Latin America, Asia Pacific and Middle East and Africa.

Princeton, New Jersey, Us

• Hired and developed highly motivated Regulatory teams in Austin, TX and Lyon, France to support Extremity Reconstruction new product introduction and sustaining compliance activities.• Managed and lead Extremity Reconstruction Regulatory acquisition team for Ascension Orthopedics, Tarsus Medical, Metasurg and Tornier acquisitions/product purchases.• Managed global aspect of product registrations providing key support and documentation to assist International Regulatory team in meeting global registration objectives.• Successfully navigated through the up classification of hemi shoulder arthroplasty in Australia securing current reimbursement payment code of CHRA Hemi Shoulder through a direct TGA Conformity Assessment.• Authored key FDA Submissions leading to Clearance of several important Extremity Reconstruction products including:Titan Shoulder Arthroplasty System – K142413Freedom Wrist Arthroplasty System – K132250 Cadence Ankle Arthroplasty System – K151459

Princeton, New Jersey, Us

Created, implemented and maintained Juvent’s Quality Management System in accordance with ISO 13485:2003 Standard, ISO 14971:2000 Standard, FDA 21 CFR Part 820, MDD 93/42/EC and CMDR requirements. Key accomplishments included:• Recruited and trained a team to establish a cost-effective multifunctional department with responsibility for quality assurance, order processing and inventory control. Met the team objective for generating the required quality system documentation. • Qualified a key contract manufacturer in Ireland and subsequently transferred the operation to Florida, to manufacture Juvent medical products at competitive costs. • Created a Limited Partnership in Ireland to handle European Sales and act as Juvent’s Authorized Representative. Expanded the Quality System to include the European site under Juvent’s ISO 13485:2003 Certification.• Defined the regulatory requirements for global distribution of Juvent products in eight international markets. Generated, submitted and received approval to market in 12 months resulting in an increase of 150 sale units in 2006 to 750 sale units in 2007.

Developed and implemented regulatory strategies to ensure compliance with domestic and international regulations to support the global marketing of EBI products. These initiatives included: Prepared and submitted 12 510(k) submissions for internal and external orthopedic implants. Developed submission strategy to develop EBI’s first Vertebral Body Replacement Device. Prepared and submitted 3 PMA Supplements for non-invasive and active implantable bone growth stimulators. Instrumental in the Development of a PMA Supplement for the transfer of the manufacturing of a Class III device. This initiative included compiling equipment qualifications and process validations in addition to a Quality System Review. Enhanced a positive relationship with U.S./International Government Agencies and Notified Bodies. Streamlined the Complaint Management System to ensure timely and effective complaint handling. Assisted with Third Party Audits for CE Marking ensuring compliance with the Medical Device Directive 93/42/EC and other International Standards and Regulations. Audited Design History Files to ensure completeness and compliance with both FDA QSR and ISO Design Control Requirements along with confirming documentation is complete and accurate when used to support Government Submissions.

Supervised and directed Exogen’s Quality Assurance Department, including Calibration Control, Incoming Inspections, In process Inspections, Final Inspections, Device/Patient Complaints Investigations and Resolutions, Corrective and Preventative Actions, SPC Program, Document Control, Non-Conformances, Dispositioning, and Training. Initiatives included: Coordinated Exogen’s Quality Assurance Department’s daily activities including inspections, documentation, training, and complaint investigation issues. Implemented a new Device History Record process, which reduced the amount of documentation and man-hours, with an annual savings of $18,000. Organized, created, and submitted FDA Annual Experience Reports and Quarterly Device Defect Reports. Assisted with employee development and training.

Coordinated PMA Supplement Submissions, FDA Annual Experience Reporting and Quarterly Device Defect Reporting, CE Marking including Technical File Submissions, International Registrations and Licensing, Clinical Registry Database, Liaison Between Exogen and Teijin, Limited, Exogen’s Japanese Partner. Initiatives included: Developed PMA Supplements, FDA Annual Experience Reports, Technical Files, and International Regulatory Submissions. Implemented and maintained an International Regulatory Submission Filing System. Performed Clinical Data Stratification of Patient Registry of Prescription Use Summary Reports. Registry containing over 10,000 patients. Developed scientific abstracts of clinical data stratification. Gained familiarity with clinical statistics, p-values, and statistical significance. Presented Poster Exhibit at 1999 AAOS in Anaheim California.

Education record

Education record