Senior Consultant, Global Regulatory Affairs - Becton Dickinson - Remote
(2020-01 - 2025-09)
- Reviewed MDR/IVDR remediation packages, including technical documentation, labeling/IFU, and standards/SOTA gap assessments, aligning submission-ready content and risk-based justifications for Notified Body review.
- Directed compliance initiatives aligning Corporate and Business Unit QMS with EU MDR, IVDR, and UKCA requirements, such as developing procedures, leading gap assessments and creating corrective action roadmaps to improve audit readiness and inspection performance.
- Mentored Regulatory Affairs leads and SMEs across multiple remediation workstreams, providing MDR/IVDR training and coaching to improve consistency, quality, and on-time delivery.
- Led regulatory impact assessments supporting change controls and product lifecycle continuity, providing executive recommendations on regulatory pathways, documentation, and implementation timing.
- Led cross-functional responses to FDA AINN notifications for IVD blood collection tubes, coordinating FDA engagement strategy, deficiency responses, and closure activities to reduce regulatory risk and protect market access.
Director (Consultant), Global Regulatory Affairs - Medtronic - Remote
(2021-12 - 2024-04)
- Directed MDR regulatory strategy for the Lung Health portfolio (Class I–IIa/b, including software), leading gap assessments and remediation activities supporting CE mark approvals and renewal timelines.
- Managed strategic Notified Body and Health Authority relationships, negotiating evidence expectations, clarifying review scope, and maintaining submission and audit timelines for critical deliverables.
- Provided executive oversight for MDR submissions and labeling workstreams, establishing governance and cross-functional operating cadence to accelerate decision-making and reduce rework.
- Led advertising and promotional regulatory review activities, chairing cross-functional committees to ensure claims substantiation and alignment with approved labeling and risk posture.
- Mentored and developed regulatory professionals through structured training and succession planning initiatives supporting continuity across complex, multi-workstream programs.
Group Head, Global Regulatory Affairs Dir. (Medical Devices / Combination Products Adv.) - Bausch Health - Bridgewater, NJ
(2017-10 - 2019-11)
- Served as Steering Team Regulatory Affairs Lead for the transition of ~200 technical files across 5 business units from MDD to MDR, prioritizing high-revenue and high-risk products to retain CE marks and maintain EU market access.
- Developed the Regulatory Affairs organizational structure, hiring and managing approximately 30 consultants while directing an additional 50 RA FTEs supporting successful Notified Body CE mark approvals under MDR requirements.
- Provided executive-level Regulatory Affairs leadership for U.S. and global product development programs, leading a 6-person RA team and advising senior leadership on risk-based decisions supporting compliant marketing and labeling claims.
Senior Dir., Global Regulatory Affairs/Quality Assurance (Head of Medical Devices/Combination Products Adv.) - Bayer Pharmaceuticals - Whippany, NJ
(2014-01 - 2017-10)
- Managed global regulatory teams supporting high-risk devices across multiple international sites, establishing strategy, objectives, and budgets to maintain Health Authority approvals, inspection readiness, and lifecycle compliance.
- Led cross-functional preparation for an FDA Advisory Committee for an implantable Class III device, including executive narrative development, data alignment, and presentation strategy supporting a successful meeting outcome.
- Drove post-Advisory Committee regulatory strategy, including study plan development addressing FDA PSS522 requirements and alignment with FDA labeling guidance, enabling approval within defined timelines.
- Provided regulatory leadership during temporary suspension of ISO 13485/CMDCAS and CE mark certificates, managing enterprise-wide impact assessments, audit execution, and HA/NB communications supporting successful reinstatement efforts and recognition through a Bayer Leadership Award.
- Oversaw preparation and filing of PMA supplements, annual reports, change notifications, design dossiers, global submissions, and Q-Sub interactions, ensuring consistency and completeness across regions.
- Served as senior regulatory representative on the Advertising and Promotional Review Committee, providing risk-mitigation guidance and final approval for compliant promotional materials and claims.
- Developed SOPs and delivered cross-functional regulatory training, provided regulatory strategy for combination and consumer health products, and conducted due diligence assessments for potential device acquisitions.
Vice President, Global Regulatory Affairs - ElectroCore Medical, LLC - Morris Plains, NJ
(2012-03 - 2013-10)
- Served on executive leadership team, developing commercialization strategy, business planning, and corporate objectives.
- Built the Global Regulatory Affairs function end-to-end, including SOPs, governance, and scalable processes supporting compliant growth, commercialization, and financing milestones.
- Recruited and led global teams and external experts supporting registrations, post-market commitments, and Health Authority interactions while balancing cost, capacity, and regulatory risk.
- Drove global market expansion strategy across Asia-Pacific, EMEA, Australia, and the Americas for a novel non-invasive vagal nerve stimulator, aligning regulatory sequencing with business priorities.
- Defined and led regulatory strategy for the company's first PMA submission, partnering with clinical teams on study design and labeling strategy to establish approval roadmaps and governance processes.
- Established cross-functional post-market surveillance processes to meet global requirements, improving signal detection, escalation, and reporting discipline across markets.
Global Regulatory Affairs Director - Neostrata Company, Inc. - Princeton, NJ
(2011-09 - 2012-02)
Global Regulatory Affairs/Quality Assurance Director - Integra LifeSciences Corp. - Plainsboro, NJ
(2010-04 - 2011-09)
Regulatory Affairs Manager - LifeCell Corp. - Branchburg, NJ
(2007-05 - 2010-03)
Regulatory Affairs Specialist - LifeCell Corp. - Branchburg, NJ
(2006-05 - 2007-05)
Project Manager / R&D Engineer - Stryker Orthopaedics Corp. - Mahwah, NJ
(2002-04 - 2006-05)
R&D Engineer - Stryker Orthopaedics Corp. - Mahwah, NJ
(1999-07 - 2001-09)
Manufacturing Engineer - Datascope Corp. - Mahwah, NJ
(1999-01 - 1999-07)
