MELISSA DEHASS
Dover,PA
Summary
I have a BS in biology, a certificate in regulatory compliance, and an MBA. I have 20+ years in medical devices and pharmaceuticals, working across the product life cycle, from development to post-market. I have proven cross-functional experience and uses this skillset to support new product development and assess design changes from both a regulatory and quality perspective. I have authored regulatory strategies, 510(k)s, a PMA supplement, NDA supplement, and technical files. I have experience with QMS development and improvement, and with supporting a company through ISO certification. I am a certified internal lead auditor and has conducted internal and supplier audits as well as hosted FDA and notified body audits. Through my experiences working for small and large medical device manufacturers, I take a business-balanced approach to regulatory and quality.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Principal
RQM+
01.2020 - Current
- Provide clients with industry-leading regulatory and quality consulting and engineering services throughout the entire product lifecycle, for both small and large firms
- Preparation of regulatory strategies and assessments, update technical files, creation 510(k) submissions for key product changes/launches, completion of pre-submission documentation, conducted pre-submission meetings with FDA
- Limited experience with breakthrough designation and STEP submissions to FDA·
- Authored PMCF protocols, plans and reports, PMS plans, PSUR/PMS reports.
- Assisted with the documentation of usability engineering, clinical evaluations, and risk management for new product lines as well as keeping this documentation current for existing product lines
- Performed gap assessments and remediation activities and/or generation of quality management system documents policy and procedure documentation for companies for best fit practices and regulatory compliance
- UDI/label compliance support
- Built strong relationships with clients, fostering long-term partnerships and repeat business.
- Served as a trusted advisor for clients navigating complex industry landscapes.
Regulatory Affairs/Quality Assurance/Quality Control Manager
Peregrine Surgical
03.2015 - Current
- Navigates the design control process through regulatory requirements.
- Participated in regular management review meetings, providing updates on quality control performance and suggesting areas for improvement.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
Independent Consultant
Melissa DeHass
11.2011 - 12.2022
- Preparation of regulatory filing for various medical device products
- Preparation and/or consultation on regulatory strategy for various medical device and combination products
- Quality Compliance support, to include auditing, response to Notified Body findings, quality system implementation/review.
- Labeling support
- Handled confidential customer business and operational information.
- Fostered strong relationships with clients through consistent communication and collaboration.
- Managed multiple projects concurrently, ensuring timely delivery and high-quality results.
Vice President, Quality and Regulatory
HR Pharmaceuticals
03.2016 - 08.2017
- Oversight over all aspects of quality management and responsible for implementation and maintenance of all regulatory requirements (MDD, CMDCAS, FDA).
- Collaborated with senior management to develop strategic initiatives and long term goals.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Established performance goals for department and provided methods for reaching milestones.
- Hired and managed employees to maximize productivity while training staff on best practices and protocols.
- Identified opportunities to improve business process flows and productivity.
- Mitigated regulatory risks by overseeing adherence to insurance and safety regulations.
- Ensured regulatory compliance at all times by implementing robust internal controls systems coupled with proactive monitoring mechanisms.
Corporate Regulatory Affairs Manager
DENTSPLY Corporate
05.2014 - 03.2015
- Support development, implementation, and management of regulatory strategies and tactics for effective and expeditious approval of new products, as well as commercialization of products in the US, EMEA and other OUS markets.
- Streamline 510(k) process between Corporate office and divisions.
- Work with divisions for compilation and preparation of all regulatory submissions.
- Monitor global regulatory affairs applicable to medical device and pharmaceutical initiatives, as well as trends and requirements impacting the development and commercialization of the products and anticipated new products.
- Advise department members and ensure that the Company is in compliance.
- Participate in formulating strategies to optimize product approvals and global opportunities of new and existing products, based on a broad understanding of regulatory requirements throughout the global marketplace for medical devices.
Manager, Corporate Regulatory Affairs
DENTSPLY Corporate
07.2013 - 05.2014
- Introduction to revised risk management requirements and implementation strategy (BS EN ISO 14971: 2012) to global divisions
- Introduction of Unique Device Identification requirements and implementation strategy to global divisions.
Director, Regulatory Affairs
Unilife Medical Solutions, Inc.
01.2011 - 07.2013
- Drive development, implementation, and management of regulatory strategies and tactics for effective and expeditious approval of new products, as well as commercialization of the Company’s products in the US and in international markets.
Senior Manager, Regulatory Affairs
Unilife Medical Solutions, Inc.
03.2009 - 01.2011
- Successful registration as a small business within first four weeks
- Successful completion of Notified Body audit, allowing certificates to transfer and continuous product supply within first eight weeks
- Clearance of multiple device premarket submissions (510(k)) within first 6 months.
Regulatory Affairs Specialist III
DENTSPLY International, Pharmaceutical Division
08.2007 - 03.2009
- Assist with preparation of NDA Supplement for implementation of new test methods (API)
- Maintain and update European certification under mutual recognition procedure (MRP).
Regulatory Affairs Associate III
DENTSPLY International, Specialty Materials Division
05.2006 - 08.2007
- Preparation of PMA supplement for manufacturing facility change for natural and synthetic bone graft devices
- Installation of quality system to support manufacturing facility change
- Facility registration.
Regulatory Associate
Cambrex Bio Science Walkersville, Inc.
02.2005 - 05.2006
Senior QA Compliance Auditor, Endotoxin detections, Contract Fill/Finish, Contract Sterilization
Cambrex Bio Science Walkersville, Inc.
10.2002 - 02.2005
QA Compliance Auditor, Cell Therapy Services
Cambrex Bio Science Walkersville, Inc.
11.2001 - 10.2002
Technical Services Representative, Endotoxin Detection
Cambrex Bio Science Walkersville, Inc.
03.2001 - 11.2001
Technical Editor, Standards Division
United States Pharmacopeia, Inc.
05.1999 - 03.2001
Education
MBA - Management
Mount Saint Mary's University
Emmitsburg, MD05.2010
Graduate Certificate - Regulatory Compliance
Hood College
Frederick05.2005
Bachelor of Science - Biology
Mount Saint Mary's College
Emmitsburg, MD05.1999
Skills
- Global Regulatory Affairs
- 510(k), Technical Files, PMA , NDA
- QMS Development and Process Improvement
- Design Control
- Supplier Quality
- Gap Assessments/Audit Preparedness
- Internal Auditing
- Post-Market Activities
- Risk Management
- ISO 13485:2016
- 21 CFR Part 820
- EU MDR 2017/745
Certification
Exemplar Global Lead Auditor Certified for ISO 13485 (Oriel STAT A MATRIX)
Education
05/2010, 05/2005, 05/1999
Tel
717-476-0702
Diverseregulatoryexperience
- Endotoxin detection
- Dental equipment and accessories, implants, and resorbable materials
- Wound healing
- Ophthalmic surgical devices
- General hospital devices
- Combination products for drug delivery
References
Available upon request
Timeline
Principal
RQM+
01.2020 - Current
Vice President, Quality and Regulatory
HR Pharmaceuticals
03.2016 - 08.2017
Regulatory Affairs/Quality Assurance/Quality Control Manager
Peregrine Surgical
03.2015 - Current
Corporate Regulatory Affairs Manager
DENTSPLY Corporate
05.2014 - 03.2015
Manager, Corporate Regulatory Affairs
DENTSPLY Corporate
07.2013 - 05.2014
Independent Consultant
Melissa DeHass
11.2011 - 12.2022
Director, Regulatory Affairs
Unilife Medical Solutions, Inc.
01.2011 - 07.2013
Senior Manager, Regulatory Affairs
Unilife Medical Solutions, Inc.
03.2009 - 01.2011
Regulatory Affairs Specialist III
DENTSPLY International, Pharmaceutical Division
08.2007 - 03.2009
Regulatory Affairs Associate III
DENTSPLY International, Specialty Materials Division
05.2006 - 08.2007
Regulatory Associate
Cambrex Bio Science Walkersville, Inc.
02.2005 - 05.2006
Senior QA Compliance Auditor, Endotoxin detections, Contract Fill/Finish, Contract Sterilization
Cambrex Bio Science Walkersville, Inc.
10.2002 - 02.2005
QA Compliance Auditor, Cell Therapy Services
Cambrex Bio Science Walkersville, Inc.
11.2001 - 10.2002
Technical Services Representative, Endotoxin Detection
Cambrex Bio Science Walkersville, Inc.
03.2001 - 11.2001
Technical Editor, Standards Division
United States Pharmacopeia, Inc.
05.1999 - 03.2001
MBA - Management
Mount Saint Mary's University
Graduate Certificate - Regulatory Compliance
Hood College
Bachelor of Science - Biology
Mount Saint Mary's College
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