SENIOR REGULATORY AFFAIRS SPECIALIST
Job Title: Senior Regulatory Affairs Specialist
Reports To: Regulatory Affairs Manager
FLSA Status: Exempt
Effective Date January 2022
Primary Purpose: These individuals have an integrated knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures required to support the Facet Regulatory Affairs department for both national and international regulatory activities.
- Maintenance of CE Technical files to the current Medical Device Directive (93/42/EEC for Medical Devices) or Medical Device Regulation (2017/45).
- FDA Premarket Submissions.
- Apostille and Legalization of ISO Certificates, Certificate to Foreign Governments, Health Canada Product Registration, and other country registration as required.
- Research of regulatory requirements and legislation.
- Coordination and support of technical and scientific regulatory activities, including CE Conformity Mark, FDA 510(k) filings, and regulatory and quality audit participation.
- Technical process improvement and Regulatory Procedure creation and maintenance as needed.
- Post Market surveillance, including supporting complaint investigations and customer replies.
- Other duties may be assigned.
- Bachelor’s degree (B.A. or B.S.) from a four-year college or university in applicable field.
- Equivalent combination of work experience and education will be considered.
- 1-2 years of related experience.
- Usually works with limited supervision, conferring with superior for direction.
- Is expected to collaborate internally and externally to provide action or decision points for departmental approval.
- Experience with controlled documents, cGMP, cGDP, regulatory strategy, and risk / benefit analysis.
- Experience in MS Office required.
- Excellent written and verbal communication and interpersonal skills required.
- Minimum of 3-4 years working in a medical environment preferred.
Skills and Experience:
- Spreadsheet and Statistical modeling skills.
- Possess and applies comprehensive knowledge of concepts to the completion of significant assignments.
- Ability to deal with quality issues proactively both tactically and strategically.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Supervisory Experience.
- Molding and Packaging Experience
- Stamping Experience
- Lean Six Sigma
- ISO 13485
- Project Management
- Time Management: Performs assigned tasks/projects in time allotted; plans accordingly to meet productivity goals; prioritizes tasks/projects appropriately.
- Quality of Work: Performs assigned tasks with accuracy; takes pride in work; follows all quality programs, processes, and procedures.
- Job Knowledge: Has a clear understanding of job duties and responsibilities; can demonstrate knowledge and understanding of job duties and responsibilities; demonstrates necessary technical skills throughout work.
- Problem Solving: Proactively identifies problems; works methodically to identify root causes and come up with possible solutions; resolves problems considering all factors including efficiency, costs, benefits, and risks.
- Initiative: Has a drive within self to do a better job; seeks opportunities to improve and learn more; takes on additional responsibilities; drives projects forward.
- Communication: Provides accurate and clear information in a timely matter; listens; uses appropriate words and tone verbally and in writing; presents information in a way that is thorough and understandable.
- Relationships: Respects others; works to find common ground when dealing with issues; team player; effectively works with other functions.
- Self-Development: Self-aware of personal development opportunities; creates a plan for continued development; works with manager to accomplish development activities; invests in self.
- Safety: Follows all safety programs, processes, and procedures; identifies and reports potential hazards or violations; drives safety initiatives and policies.
- Drive for Results: Do everything possible to meet goals or deadlines; consistently meet or exceed commitments; aggressively pursue all assignments and projects until completion, focusing your own and others’ energy on what really makes a difference; actively seeking out opportunities to improve delivery of service and new ways of working.
Please submit your resume to firstname.lastname@example.org.