- Cultivate and expand expertise in regulatory areas pertaining to Medical Devices, In Vitro Diagnostics (IVD), and/or Software as a Medical Device (SaMD), engaging with potential clients and staying updated on industry trends.
- Actively participate in client bid defense meetings for prospective projects across the medical device, IVD, and SaMD sectors, providing valuable insights and strategic guidance.
- Monitor regulatory changes globally and provide proactive advisory services to companies in the medical device, IVD, and/or SaMD sectors, ensuring compliance with new regulations and standards.
- Offer specialized Subject Matter Expert (SME) consulting on regulatory strategy, submissions, and operational excellence tailored to each sector's unique requirements.
- Assist in developing technical documentation and design dossiers to facilitate CE marking, 510(k), or other approval procedures for medical devices, IVDs, and SaMD.
- Provide SME consulting for regulatory compliance, covering EU Directives, new EU Regulations (MDR & IVDR), FDA requirements, and other relevant regulations applicable to medical devices, IVDs, and SaMD.
- Lead comprehensive gap analysis projects for MDR, IVDR, and SaMD regulations, assessing existing systems, processes, and departments against new requirements.
- Collaborate with stakeholders to identify necessary changes to compliance processes and update associated documentation for each sector.
- Support the implementation of changes to organizational risk management processes for medical devices, IVDs, and SaMD.
- Conduct thorough device risk assessments and ensure compliance with ISO 13485, MDSAP, and relevant regulatory standards for each sector.
- Aid in constructing Technical Files according to new MDR & STED format for medical devices, IVDs, and SaMD, including essential requirements evaluation reports, risk management documentation, and clinical evaluation reports.
- Provide support for regulatory submission projects across medical devices, IVDs, and SaMD, ensuring adherence to market and product-specific requirements.
- Establish and maintain professional relationships with direct and indirect clients in the medical device, IVD, and SaMD sectors, including Health Authorities and Notified Bodies.
- Take responsibility for operational project planning across all sectors, preparing weekly plans aligned with project timelines and ensuring team members are appropriately trained.
- Stay updated on market news and trends across medical devices, IVDs, and SaMD, sharing relevant insights with the team and clients.
- Support marketing activities such as webinars, blog writing, and participate in presales meetings with prospective clients across all sectors.
- Assist in internal and external audits as required, ensuring compliance with regulatory standards for medical devices, IVDs, and/or SaMD.
- Provide regular status reporting to stakeholders according to an agreed communications plan, encompassing all sectors.
- Bachelor's Degree in pharmacy, Regulatory Affairs, or relevant Life Sciences fields; Master's Degree preferred.
- RAC certification in Medical Devices is advantageous.
- Minimum 5 years of experience in medical devices, IVDs, or SaMD within industry, consultancy, or regulatory agencies, with expertise in manufacturing, R&D, quality, or regulatory roles.
- Technical proficiency in MDD/MDR, IVDR, ISO 13485 standards, and IMDRF requirements across medical devices, IVDs, and/or SaMD.
- Strong stakeholder management and project management skills applicable to each sector.
- Excellent written and verbal communication, strategic thinking, and problem-solving abilities.
- Customer-focused mindset with strong organizational and time management skills, adaptable to diverse regulatory landscapes.
-
Medical Device Sales Representative
2 days ago
AposHealth Philadelphia, United States**About us** · We at AposHealth are passionate about revolutionizing health and wellness by simply helping people move better and live better. How do we do that? Our flagship solution, Apos, is doing just that. Our footworn FDA-cleared medical device, with a 96% satisfaction rate ...
-
Medical Device Sales Representative
3 days ago
AposHealth Camden, United States**About us** · We at AposHealth are passionate about revolutionizing health and wellness by simply helping people move better and live better. How do we do that? Our flagship solution, Apos, is doing just that. Our footworn FDA-cleared medical device, with a 96% satisfaction rate ...
-
Medical Device Technician
1 week ago
Invent Medical USA LLC. Warminster, United StatesNo experience required We're looking for motivated individuals who are eager to learn and create next-generation products. As a 3D Printed Medical Device Technician, you will work with cutting-edge technology, such as laser plotters, and assemble orthopedic and prosthetic 3D prin ...
-
Medela LLC Philadelphia, United StatesMedical Device, Clinical Support Manager-Wound Care · MEDAXIS LLC · (Negative Pressure Wound Therapy devices produced by Medela LLC) · Remote position with 70% of travel required · - This position is ideal for a currently licensed RN with hands-on wound care/negative pressure exp ...
-
Medical Device Sales
2 weeks ago
Medsurg Sales Staffing Philadelphia, United StatesJob Description · Job DescriptionWe are seeking a highly motivated and skilled Medical Device Sales Representative with: a minimum of 2 years of direct sales experience in the EMS sector · Bachelor's degree · Territory is Philly, DC, Delaware, MD. You can be located anywhere in t ...
-
Medical Device Sales
1 week ago
Medsurg Sales Staffing Philadelphia, United States PermanentCompany with well know, high quality product lines has open territory. Surgical instruments and devices sold to hospital and ambulatory surgery centers. The company offers a generous base salary of 75k and 150k at plan, unlimited commission plan plus bonuses, kickers and contests ...
-
Medical Device
1 week ago
Medsurg Sales Staffing Cherry Hill, United StatesJob Description · Job DescriptionMedical device company looking for experience rep to sell high tech implantable medical device. Unique opportunity entails calling on referring physicians and working with patients in offices for half of the week and then being present at implant ...
-
Regulatory Affairs, Medical Device
3 weeks ago
NEUROVUE Philadelphia, United StatesExpertise Development and Client Engagement: · Cultivate and expand expertise in regulatory areas pertaining to Medical Devices, In Vitro Diagnostics (IVD), and/or Software as a Medical Device (SaMD), engaging with potential clients and staying updated on industry trends. · Act ...
-
Medical Device Sales Representative
3 days ago
Breakaway Consultants Philadelphia, United StatesJob Description · Job DescriptionWe are seeking a Medical Device Sales Representative to join our client's growing team Medical Sales is not mandatory, however, B2B sales and documented successes are. You will focus on driving new business by growing the current client list in th ...
-
Medical Device Sales Representative
3 days ago
AposHealth New Castle, United States**About us** · We at AposHealth are passionate about revolutionizing health and wellness by simply helping people move better and live better. How do we do that? Our flagship solution, Apos, is doing just that. Our footworn FDA-cleared medical device, with a 96% satisfaction rate ...
-
Medical Device Repair Technician I
3 weeks ago
Path Engineering Cooper City, United StatesJob Description · Job DescriptionRoleAs a Medical Device Repair Technician I (also known as Medical Equipment Technician, Biomedical Equipment Technician), you will play a crucial role in the healthcare industry by ensuring the proper functioning and maintenance of medical device ...
-
Medical Device Repair Technician I
3 weeks ago
STERIS - Commercial Operations Cooper City, United StatesJob Description · Job DescriptionOverviewWe are seeking a skilled and dedicated Medical Device Repair Technician I to join our team at our facility located in Cooper City, FL as a Medical Device Repair Technician I, you will play a crucial role in ensuring the proper functioning ...
-
2nd Shift Machine Operator, Medical Device
2 weeks ago
XL Precision Technologies, Inc. West Chester, United States**XL Precision Technologies Inc** is recruiting for **Operator - Second Shift**, located in West Chester, PA. · XL Precision Technologies Inc (XL-PT) is a subsidiary of XL Precision Technologies Ltd out of the UK. The parent company has been very successful in the medical device ...
-
Medical Device Territory Account Manager
3 weeks ago
Tactile Medical Camden, United StatesOverview: · The Territory Account Manager is responsible for educating therapists, physicians and patients on Tactile Medical Products in an assigned territory. Responsible for establishing sales strategies to attain monthly, quarterly and annual sales goals. Responsible for pen ...
-
Quantum Dynamics Lambertville, United StatesJob Description: Independent planning, execution and documentation of conformity assessment procedures (audits and/or technical documentation) for manufacturers of active medical devices and their suppliers according to ISO 13485 or ISO 9001 as well as the Medical Device Directiv ...
-
Jameson Legal Philadelphia, United States Full timeOur client, a large mid-market full-service firm is seeking an Associate in its Mass Torts team in multiple locations. This firm gives BigLaw quality work without the BigLaw hours targets. Strong candidates will have between two and four years of experience from a strong litigati ...
-
Medical Device Engineer
2 weeks ago
Kane Partners LLC King of Prussia, United StatesJob Description · Job Description · Kane Partners is seeking both a talented Mechanical Engineer and Electrical Engineer to join our team and help our company get to the next level. · The Medical Device Engineer will research, plan and design products, systems and services rela ...
-
Medical Device Engineer
2 weeks ago
Kane Partners LLC King of Prussia, United StatesJob Description · Job DescriptionKane Partners is seeking both a talented Mechanical Engineer and Electrical Engineer to join our team and help our company get to the next level. · The Medical Device Engineer will research, plan and design products, systems and services related t ...
-
Employee (m/f/d) Medical Device Processing
2 days ago
Nexus Innovations Washington Crossing, NJ, United States Freelance- VAMED is a leading service provider in the healthcare sector. We plan, construct, and manage healthcare facilities throughout Germany. Our work is the foundation for the safe operation of technology in over 440 hospitals. Our approximately 2,800 colleagues live a culture of ope ...
-
Medical Device Inspector
3 weeks ago
AstrixTechnology LLC Wilmington, United StatesJob Description · Job DescriptionA large biopharmaceutical company with a great reputation is seeking a medical device inspector with minimal manufacturing and technical experience. · Pay Rate: $17 an hour · Shift: · Contract Full-time (M-F 7am-3:30pm 1st shift) · Convert to Full ...
Regulatory Affairs, Medical Device - Philadelphia, United States - NEUROVUE
Description
Expertise Development and Client Engagement:
Advisory Consulting Services:
Documentation and Compliance Support:
Gap Analysis and Process Improvement:
Risk Management and Quality Assurance:
Technical File Development and Submission Support:
Client Relationship Management and Project Oversight:
Market Intelligence and Marketing Support:
Audits and Reporting:
Education & Experience:
Skills and Competencies:
Regulatory Affairs, Medical Device professionals in Philadelphia
-
Andrew Judge
Design engineer. Passion for power systems
-
Barry Collins
Cyber Security
-
Devin O'Brien
CF Speech-Language Pathologist
-
Carl Denys
Senior Executive - Medical Devices - Go to Market
-
Michael Roy
Senior Cardiovascular Clinical/Sales Specialist