Founder & Managing Director Resume Example

Directs all activities related to business development, growing and sustaining company offerings involving the regulatory environment for medical device products with an emphasis in biocompatibility testing. Performs overall preclinical / regulatory strategy development for clients. Facilitates APS business development activities. Provides scientific / technical oversight of biocompatibility related activities. Provides input for regulatory strategies and requirements on medical device products internally and with clients to ensure appropriate regulatory strategy and timely, accurate regulatory submissions.

Accomplishment

• Partnering with the APS President and executive management in establishing APS Regulatory Consulting Services as a new division of APS.
• Led a sponsor in successfully obtaining Expedited Access Pathway (EAP) Designation and priority review for a 3D Printed Bioabsorbable Tracheobronchial Splint on February 24, 2017.
• Established and implemented a streamlined process for responding to US FDA and other regulatory agency request for additional information on submitted preclinical test reports.
• Consistently facilitated business operations for regulatory and biocompatibility services, including presenting offerings to current and potential clients, assisting in the preparation of quotes for services, and providing ongoing regulatory and technical support.
• Business development, representing APS Regulatory Services at conferences and exhibits.
• Managing and guiding large and small business clients through the process of EU MDR Remediation by addressing the requirements that include but not limited to device classification, establishing Economic Operators, completing gap assessments for products CE Marked under MDD, as well as, implementation (i.e., collaborating with cross-functional team to establish the Safety and performance checklist, Technical File, risk management according to ISO 14971, UDI System, Post Market Surveillance (PMS), Post Market Clinical Follow-Up (PMCF), Clinical Evaluation according to MEDDEV 2.7.1 Rev.4., and EUDAMED registration per the EU MDR).

Collaborated with the St. Jude regulatory staff in the preparation of an original PMA (traditional) for expansion of an indication for use for a 510k cleared product. Responsibility included but not limited to the following PMA sections; device manufacturing (quality systems and software), animal studies summary, proposed labeling, referenced performance standard/voluntary standard, environmental assessment under 21 CFR 25.20(n) ((d)(i) or (ii), pediatric use - per 515A(a)(2) of the FD&C Act, statements/certifications/declarations of conformity, issues identified by FDA prior to PMA submission. Participated in cross-functional product development and manufacturing project teams. Provided guidance to project team on content for the PMA submissions for assigned sections. Perform other duties and projects as assigned by Manager, Regulatory Affairs.

Accomplishments

Client:ValidantandSt. Jude Medical

Project Title: Project Manager, RA

CommencingDate: Sep 2017

Completion Date: Dec 2018

Location: Abbott (SJM) CRM – Sylmar, CA

Assist Client with both US and EU product submissions for CRM product.

• Assist Client with gathering regulatory impact assessments from Client international regulatory.
• Assist Client with assessment of changes and maintaining documentation on changes for FDA 30-Day Notices, Annual Reports, as well as TUV changes (substantial and insubstantial)
• Provide other services as mutually agreed upon by the parties.
• Contractor Personnel shall provide other services as mutually agreed upon by the parties.

Collaborated with Natus Medical in-country affiliates and distributors in the registration of Natus Medical products and maintenance of approvals in Latin America countries, Australia, Eastern Europe, Canada, Malaysia, Taiwan, Japan, China, and Indonesia

Client: Natus Medical

Role: International Regulatory Affairs Manager

Commencing Date: 2 January 2019

Completion Date: 30 June 2019

Project Length: 6 months

Accomplishments:

• Collaborated with the in-Country Natus Medical RA affiliates and distributors in the creation of manufacturing and product change assessment tools, product registration aid for Latin America countries, Eastern Europe and South East Asia.
• Processed required documents for new product approvals and license renewals.
• Reviewed and approved engineering change orders.
• Completed International pre-notification of engineering change orders for assessment of regulatory impact.