Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges. We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing.
RCA is currently recruiting for a Combination Products Subject Matter Expert (SME) to consult with our global clients. This position is remote based and candidates will work at the Client site or from home in any market in the United States.
The successful individual will serve as a subject matter expert on combination products requirements in accordance with FDA / EU MDR / ISO regulations, standards and industry best practices. This role will be involved in the quality / regulatory related activities throughout the entire combination product’s lifecycle.
- Participate in client scoping calls and assist with the development of SOW’s.
- Provide subject matter expertise and leadership on combination product development.
- Work with clients to ensure the content of regulatory submission for the combination product is complete and satisfies the requirements of the regulatory bodies in US, EU, etc.
- Experience with creation and / or remediation of Design History File for the device portion of the combination product.
- Creation of the content for the relevant device sections of the regulatory submission package.
- Work with both internal and external project team members to ensure that all design development work meets applicable FDA and ISO QMS requirements. Assure that the Design Control process is being followed and utilize appropriate techniques such as risk analysis, usability, statistical data analysis, etc.
- When necessary, development and implementation of the quality system that meet domestic and/or global requirements. Define new or propose improvements to the existing processes, create or update SOPs, develop and conduct training on the new / modified SOPs.
- Minimum Bachelor’s degree in engineering, life sciences or relevant discipline.
- Requires a minimum of 5 years of experience as a quality, engineering or manufacturing professional in combination products field.
- Candidate should have a strong working knowledge of the medical device and combination product regulations and requirements, at minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366, EU MDR, relevant FDA guidance, relevant consensus standards and common specifications in EU MDR.
- Experience with Drug/Device or Biologic/Device combination products is a must.
- Candidate should have practical experience in combination device R&D, Quality, design controls, new product development life cycle, risk management (including FMEA), usability, verification /validation (V&V), DHF creation, and post market support.
- This role requires effective communication and collaboration skills, including ability to interact with all levels of management.
- Strong ability to multitask is required.
- Experience in the development or oversight of quality systems is highly desirable.
- Experience with developing combination products that include more complex drug/biologic delivery mechanism than prefilled syringes and potentially have electronic and embedded software or use connected health solutions is a plus.
Diversity and inclusion programs at Regulatory Compliance Associations® (RCA) are strategically designed to attract, develop, and retain the industry’s most skilled and professionally talented individuals regardless of their race, sexual orientation, religion, age, gender, or disability status.