Regulatory Affairs Specialist
About the job
Plan, manage, and implement processes to ensure compliance with applicable regulatory requirements. Interface with FDA, Notified Body, and other Regulatory Agencies. Aid in regulatory strategy decisions. Provide input on regulatory requirements for new product development or design/process change projects. Oversee device registrations, listings, certifications, and technical documentation.
Essential duties and responsibilities
- Provide support for the regulatory department to ensure efficient and compliant processes
- Execute tasks and partner across business functions
- Assist in SOP development and review
- Participate in worldwide regulatory submissions
- Review promotional and advertising materials to provide regulatory compliance input and ensure that they are effectively presented to substantiate claims
- Provide regulatory input to product lifecycle planning
- Assist in the development of regional regulatory strategy
- Understand, investigate and evaluate applicable regulations in order to assess regulatory implications for approval
- Determine and communicate submission and approval requirements
- Compile, prepare, review and submit regulatory submissions to authorities
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
- Assist compliance with product post-marketing approval requirements
Education, experience, and skills required
- B.S. or M.S. in law, medicine, pharmacy, engineering, or another relevant scientific discipline
- Six or more years experience in medical devices
- One year of professional experience in regulatory affairs or in quality management systems relating to medical devices
- Experience with regulatory submissions (i.e. 510K, De Novo, PMA, EU Notified Body, Japan PMDA)
- Excellent writing skills
- Ability to organize and prioritize work and to meet deadlines
Physical demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time. Occasionally the employee will be required to lift or move at least 50 pounds.
To Apply
Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.
Resumes from recruiters will not be accepted.