: Senior Regulatory Affairs SpecialistLOCATION
: Delta Park, Segensworth, Hampshire UKSCOPE
Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaise with internal functions such as Manufacturing, R&D, Operations and Marketing to provide any necessary information and documents (outside the Master Technical Files), requested by the regions to assist in global product registration activities.JOB SUMMARY
The Senior Regulatory Affairs Specialist will provide Regulatory support and direction to products from concept to launch. The Sr. RA Specialist follows the regulatory strategy for assigned corporate projects. Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company's regulatory compliance status.ESSENTIAL FUNCTIONS
KNOWLEDGE, SKILLS AND ABILITIES
- Complies with the regulatory requirements (MDD and MDR) and international standards within the region
- Prepares Technical Files for CE approval Represents the perspective of regulatory affairs to the company
- RAID process as a base product lifecycle RAID with revision control and central files. Collaborates with the Manufacturing sites and Global RA functions to review the completed RAIDs and ensure RAIDs are properly approved and filed
- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed.
- Maintains regulatory files and documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports.
- Supplies samples, packaging, and assists in scheduling and managing outside testing labs and CRO activities.
- Utilize projects tools to effectively track and communicate project development to meet agreed upon schedules.
- Implements and executes on regulatory plans and interfaces with project team members, both within the organization and with a diverse range of external groups, to drive corporate initiatives to completion.
- Support RA Project core team members on development teams, providing RA guidance, and project regulatory assessments.
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Liaise with internal functions such as Manufacturing, R&D, Operations and Marketing to provide any necessary information and documents (outside the Master Technical Files), requested by the regions to assist in global product registration activities.
- Independently manage multiple projects, department initiatives and day to day tasks.
- Keeps abreast of regulatory requirements, this includes monitoring FDA and other agencies regulations and standards.
- Respond to corporate inquires and follow up to internal processes.
- Excellent oral and written communication skills, with ability to communicate with diverse populations.
- Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulation and graphing).
- Project management, technical writing and analytical skills.
- Effective communicator; able to convey messages in a logical and concise manner. Ability to read and understand highly technical material.
- Ability to meet deadlines.
- Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
- Complies with all company policies and procedures.
- Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relation to job functions.
- Conducts self in a professional manner with coworkers, management, customers, and others.
- Models the corporate values.
- 8+ years of medical device regulatory experience.
- Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
- Medical device industry experience including strong working knowledge and experience with MDD and MDR. International Medical Device understanding would also be very helpful for this position.
- Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR, and ISO 13485.
- Experience in basic document control and the Agile PLM system is a plus yet not required.
- Strong computer skills, problem solving ability, analytical and communication skills.
- Bachelor's degree in a scientific or technical discipline from a four year college or university.
- Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
- RAC Certification preferred, but not required.