Regulatory Affairs Specialist II
The Regulatory Affairs Specialist II is responsible for filing necessary submissions and handling all regulatory authority interactions pertaining to the regulation process for product submissions. Supports necessary regulatory activities required for product market approval, and post-approval requirements.
- Prepare regulatory documentation packages, such as 510(k)s, for review and submission to regulatory agencies or to our commercial partners to achieve departmental and organizational objectives
- Assemble Technical Documentation for CE Marking under the MDR including writing and maintaining Clinical Evaluation and Post-Market Surveillance Plans and Reports
- Request and/or facilitate pursuit of legalized international registration documents such as requesting Certificates to Foreign Government (CFG) from FDA and legalization of business and federal documents by Certification of Apostille or Authentication/Legalization through Department of State and applicable Consulate
- Assists in developing procedures to ensure regulatory compliance
- Review preclinical and clinical protocols and reports for compliance with GLP and GCP requirements, respectively
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Maintain regulatory files/database and chronologies in good order, both internal and external (e.g., GUDID, EUDAMED, GS1, etc.)
- Review labeling and engineering changes for compliance with regulatory filings
- Maintain current knowledge of FDA, ICH, and international guidelines
- Responsible for other duties and projects as assigned
Exercises judgment within defined procedures. Works on problems of moderate to diverse scope. Normally receives general instructions on routine work, detailed instruction on new assignments.
Bachelor’s degree, preferably in life sciences or related field
Desired Experience, Knowledge, and Skills:
- 2-5 years of regulatory affairs experience
- Experience with FDA and EU applications, supplements, and clearance/approval
- Strong organizational and follow-up skills, as well as attention to detail
- General understanding of global and U.S. regulatory processes
- Excellent project management skills with the ability to multi-task
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Excellent presentation skills, both written and in platform presentation format
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.