Position Summary: The Principal Regulatory Affairs Specialist will be responsible for developing regulatory strategies and submissions to support international and US regulatory approvals. Responsibilities include supporting regulatory activities for all stages of the product lifecycle – proof of concept through post market phases.
- Compile, prepare, review and submit worldwide regulatory submissions to regulatory
- Author EU MDR Technical Documentation and General Safety and Performance Requirements (GSPR) to support CE mark approvals.
- Write and edit technical documents to support regulatory submissions.
- Assist in the development of regulatory strategy and update strategy based on regulatory
- Provide regulatory input to product lifecycle
- Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for
- Participate in risk-benefit analysis for regulatory
- Review labeling to ensure applicable requirements are met for applicable country.
- Assess acceptability of design verification, design validation, and process validation documentation for regulatory submission requirements.
- Evaluate proposed product and manufacturing changes for regulatory filing requirements.
- Monitor impact of changing regulations and standards on product and submission
- Assess complaints for regulatory reporting and submit reports to regulatory authorities.
- Create project plans and
- Create and/or edit regulatory SOPs as needed.
- Bachelor’s degree required; in a scientific or related discipline preferred.
- Minimum of 5-10 years regulatory affairs experience in a medical device company working with Class II/III medical devices or submissions requiring clinical trials.
- Knowledge and experience with EU MDR, US IDE and PMA regulations.
- Experience with worldwide regulatory submissions and standards.
- Proficiency with MS Word, PowerPoint and Excel.
- Excellent verbal and written communication skills.
- Ability to work effectively in cross-functional team.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.