Regulatory Affairs Specialist – FT/PT
Conduct research to support regulatory submissions. Prepare and submit documentation to regulatory agencies. Ensure company compliance with all regulations and laws pertaining to company business. Compile and maintain appropriate technical documents for regulatory submissions.
Duties and responsibilities
- Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
- Prepares and facilitates regulatory submissions such as change notifications and annual reports with direction from management
- Collaborates with regulatory colleagues, quality, R&D, and clinical affairs
- Manages regulatory project plans and timelines
- Applies basic knowledge of FDA and EU regulations to provide regulatory guidance and contributes to strategic planning on project teams with direction from management
- Prepares and submits regulatory filings for international product registrations
- Maintains technical documentation
- Develops and maintains departmental processes, policies, SOPs and associated documents
- Participates in department initiatives and training
- Bachelor’s degree in science or engineering required.
- Minimum of 3-5 years’ experience in Medical Device and/or Pharmaceutical industry
- Minimum of 2 years’ experience in Regulatory Affairs
- Regulatory submission experience (CE Mark, IDE, PMA preferred)
- Effective written and oral communication, technical writing and editing skills
- Strong project management and team facilitation skills
- Team player with strong interpersonal skills
- Ability to work independently and part of a team
- Experience with cross-functional teams
- Strong organizational skills, able to multi-task, high attention to detail
- Regulatory Affairs Certification (RAC) is a plus
- Experience with international regulatory environment is a plus
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.
While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects. The employee is regularly required to stand; walk; sit; use hands and fingers, handle or feel: and reach with hands and arms.
Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.
The employee must occasionally lift and/or move office products and supplies, up to 20 pounds.
The noise level in the work environment is usually low to moderate.