What are the responsibilities and job description for the Principal Regulatory Affairs Specialist, Digital Technology position at 1014 United States of America?
The primary responsibilities of the position are to ensure regulatory compliance of SaMD, SiMD and AI/ML based products, drive regulatory processes and activities (such as regulatory strategy, product registration, change control, review of marketing materials, etc) and continue to develop strong working relationships with internal and external customers. The person will be responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of new product development, product life cycle and changes to existing products.
Key Responsibilities:
- Advise on strategies and registration requirements for for the SaMD, SiMD and AI/ML product development, ensuring compliance with all applicable regulations, guidance documents, and recognized standards (e.g., ISO 13485, ISO 14971, IEC 62304)
- Educate and advise cross-functional teams on evolving regulatory requirements and best practices specific to SaMD, clinical evidence generation, and AI/ML-based medical devices
- Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship
- Regulatory support for enquiries from customers and authorities
- Oversee, provide guidance, and if necessary, write and submit US FDA submissions, including 510(k)s, De Novo, etc, and EU MDR Technical Documentation, and interface with authorities during the review process
- Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including, including design control activities, indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio
- Review, interpret and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions
- Support base business activities, such as Annual Reports, Supplements, Labeling reviews, UDI and Change Management reviews for regulatory submission impact
- Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures
- Supports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems
- Regulatory review and approval of documents supporting the QMS and product registrations
- Participates as an active member of Industry, Regulatory or Scientific Committees, as appropriate
- Perform other duties as assigned
Skills & Experience:
- 5-10 years relevant experience, preferably in a regulatory affairs role in the life science industry or engineering
- Minimum of 5 years of experience in regulatory affairs, with a focus on software as a medical device and/or AI-based medical technologies
- Experience with SaMD, SiMD, AI/ML and Cybersecurity regulatory requirements preferred
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
- Experience with SaMD, devices containing software and medical electrical equipment
- Experience authoring and submitting medical device registrations/ licenses/submissions applicable to regional area
- Experience reviewing product labeling and advertising/promotional material for medical devices
- Experience supporting change control and new product development projects
- Knowledge of compliance with key international standards, such as ISO 13485, ISO 14971 and IEC 62304
- Demonstrate excellent communication skills
- Demonstrate strong organizational skills, including the ability to prioritize workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial
- Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize
- Proficiency in software applications, including Word, Excel, PowerPoint, SAP SharePoint and email
Qualifications/Education:
- Level of education required to have been achieved - Life Science or Engineering Degree level or equivalent.
- Experience with AI/ML algorithm validation, performance metrics, and clinical evidence generation
- RAPS Certification preferred
Travel Requirements
NMT 25% of work time.
There may be some business-related travel associated with this role dependent on project and / or local market and UK travel associated with this role because some team members are home based and face-to-face contact with line manager and peers may be required.
Attendance of relevant training and development events would be required.
Some destinations may involve overnight stay(s).
Languages
- Speaking: Yes English
- Writing/Reading: Yes English
Working Conditions (Applicable local workplace laws and statutes should be included in the description of working conditions)
This position is remote based, with occasional travel to the office. The office location for this role is Lexington, MA (US)
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