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 EU MDR Regulatory Affairs Subject Matter Expert to consult with our global clients. This position is remote based and candidates will work from home in any market in the United States. Some on-site support may be required.
The EU MDR Regulatory Affairs Subject Matter Expert is skilled at developing strategies and establishing policies according to business needs. He/she is proficient in completing medical device submissions, with successful results domestically and internationally. He/she will provide direction and oversight to the project, answer any regulatory questions that arise, as well as compiling and submitting any final documentation to regulatory agencies.
This individual should have experience with global medical device regulations and standards, device registration, clinical investigation, and the device clearance/approval processes in the EU. They assist with reviewing product promotional materials, labeling, test methods, and other relevant regulatory documentation required for device submissions for compliance with applicable regulations and policies. They will participate on project teams supporting regulatory activities, including but not limited to, regulatory strategy which may include the identification of the device classification, and determination of testing requirements for the medical device submission activities.
In addition, they may determine the appropriate regulatory pathway for the required regulatory submissions or internal documentation which may be required in situations such as proposed device changes or labeling changes.
- Participate in scoping calls and assist with development of the statement of work
- Ability to determine device classification under MDR.
- Ability to create Clinical Evaluation Report is desirable.
- Ability to assemble technical documentation
- Ability to create device specific post market surveillance plan and report
- Ability to create device specific Clinical Follow up plan and report
- Familiarity with Periodic Safety Update Report (PSUR)
- Ability to facilitate interactions with notified bodies/Competent Authorities/Authorized representatives.
- Skilled at acting as a person responsible for regulatory compliance to ensure conformity of medical devices in accordance with MDR.
- Skilled at performing conformity assessments based on a quality management system as well as an assessment of the technical documentation
- Ability to develop standard operating procedures to comply with MDR and ISO 13485:2016.
- Experienced Regulatory/Quality Professional with a minimum of 5 years experience working with EU Medical Device Directive (Council Directive 93/42/EEC) / EU Medical Device Regulations - 2017/745. Able to demonstrate a solid background in ISO 13485 and EU MDR implementation for a variety of medical devices marketed in EU. EU MDR Post-Market Surveillance (PMS) and Clinical activities is a plus.
- Minimum of a College degree; Advanced degree preferred such as a Masters or PhD, but not required. Commensurate job experience and/or expertise will be considered.
- Led/managed transition from MDD to MDR.
- Familiarity with EUDAMED
- Familiarity with MDR General Safety and Performance Requirements (Annex I)
- Familiarity with Registration of devices and economic operators;
- Familiarity with EU UDI registration, labeling, and submission
- Familiarity with Confidentiality and General Data Protection (GDPR)
- Full understanding of the EU MDR PMS and Clinical requirements with the ability to apply them to the required activities for these areas of the Regulation which include writing all the PMS/Clinical documentation (i.e. PMS Plan, PMS Report, PSUR, PMCF Plan, PMCF Report, Clinical Evaluation Plan, Clinical Evaluation Report, etc.).
- RAC Certified or other similar designation is helpful, but not required.
- Strong written and verbal communication skills. Ability to work independently onsite/remote with little or no supervision, and/or ability to work with teams to meet deadlines and drive results. Professional disposition. Positive attitude. Ability to work under stressful situations. Ability to interact with the Regulatory Authorities and/or Clients in a professional manner that comply with appropriate standards of ethics and conduct.
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.