What are the responsibilities and job description for the Regulatory Affairs Specialist – Regulatory Intelligence position at Kelly?
Kelly Services is actively recruiting for a Direct Hire opportunity in Pleasanton, CA for a Sr. Regulatory Affairs Specialist. (open to remote work)
The Senior RA Specialist – Regulatory Intelligence is responsible for the assessment of the applicability of documents of external origin (i.e., standards, regulations) and maintenance of procedures associated with regulatory intelligence (RI). The Senior RA Specialist – Regulatory Intelligence is responsible for leading and coordinating RI, proactive global monitoring, the firm connection with the Documents of External Origin (DOEO) process, and the communication/dissemination of RI information to the wider organization.
Essential Functions & Accountabilities:
- The discovery, analysis, assimilation, and communication of regulatory intelligence as input to the DOEO process. This involves keeping abreast of relevant regulatory developments, ensuring organizational readiness, and advocating for positive regulatory reform. This includes monitoring USFDA, Health Canada, ANVISA, EU European Medicines Agency, UKCA and MHRA, MedDO and Swissmedic, TGA, PMDA, NMPA, and other agency regulations and DOEO. This includes the International Medical Device Regulators Forum (IMDRF), Working Groups, Technical Committees, external conference/training attended by professional committees (i.e., Regulatory Affairs Professional Society) or sponsored by various Ministries of Health (MoH), direct MoH communications to manufacturers and external regulatory intelligence databases such as British Standards Institute Compliance Navigator or MedTech, new/revised DOEOs such as ISO standards, and other relevant technical standards.
- Apply an understanding of the underlying science as it relates to RI, for contact lens and contact lens care products.
- Actively develop an understanding of health authority inner workings, regulatory requirements, and potential interpretation of regulatory guidelines.
- Collect regional regulatory intelligence and provide monthly reports. Monitor impact of changing regulations on submission strategies and notify appropriate departmental personnel.
- Apply an understanding and working knowledge of the key global regulatory agencies.
- Maintain regulatory files and documents in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide status reports.
- Assess applicability of DOEO (i.e., standards, regulations) and maintain procedures associated with this process, including RI.
- Respond to corporate inquiries and follow up to internal processes (i.e., Regulatory Affairs Impact Documents (RAIDs), RA database, RI).
- Follow regulatory plans and interface with project team members, both within the organization and with a range of external groups, to drive corporate regulatory initiatives to completion. Liaise with internal functions such as quality assurance (QA) Operations, Operations, Manufacturing, Professional Services, Legal, RA, and Marketing to provide necessary information and documentation requested.
- As business needs dictate, work extended hours to complete daily department goals or tasks to include overtime.
- Develop and maintain RI process and other regulatory/quality systems processes as needed.
- Develop familiarity with the database-oriented software, regulatory information management (RIM) system, Agile PLM (product lifecycle management)/global RA database reporting functions reporting key performance indicators (KPIs) and rollout plans to global RA team and management (metrics analysis and reporting).
- Generate a meaningful output of RI by translating learnings to educate the business about RI and how it impacts the business. Ability to prepare and publish regulatory intelligence newsletter and presentations. Take the lead in delivering the regulatory newsletter content to the organization, as well as ownership of the content and updates to RI globally.
- Perform quality checks of global regulatory requirements and documents for appropriate categorization, redundancies, errors, and documents that are out of scope.
- Lead the development and refinement of RI processes and procedures to build efficiencies, track minutes from related meetings, and coordinate RI review meetings.
- Prepare new/revised regulatory requirements for site Management Reviews.
- Prepare MDSAP Chapter 2 data to MDSAP sites in preparation for their audits.
Qualifications
Knowledge, Skills and Abilities:
- Leadership skills and works well with others for collaboration, negotiation, and empowering of others to achieve a common goal
- Strategic and critical thinking, communication, leadership, attention to detail, self-motivation
- Excellent oral and written communication skills, with ability to communicate with diverse populations
- Must be proficient with Microsoft (MS) Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulation and graphing).
- Have familiarity with the database-oriented software and/or the Agile PLM (product lifecycle management)/global RA database reporting functions.
- Project management, technical writing, and analytical skills
- Ability to read and understand highly technical material
- Ability to meet deadlines
- Adapt readily to changes in workload, staffing, and scheduling.
- Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
- Conduct self in a professional manner with coworkers, management, customers, and others.
- Model the corporate value.
- Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR, MDSAP, ISO 13485, UKCA, MedDO, MDD, and MDR
Work Environment:
- Prolonged sitting in front of a computer
- Professional office environment
- Willing to report to work in San Ramon, CA, Victor New York, or Fareham, Hampshire
- Light lifting of documents, files, and reference books
- Works scheduled hours and is ready to work at scheduled start times
Experience:
- At least seven years of medical device industry experience (may include health authority interaction experience) to support many of the tasks a regulatory intelligence professional undertakes
- RAC Certification preferred, but not required.
Education:
- At least tertiary education in a scientific field at the bachelor’s degree level, preferred master’s or doctoral level.
- Working knowledge of medical device regulations with formal education in regulatory discipline preferred.
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You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
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