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 for review and submission to regulatory agencies or to our commercial partners to achieve departmental and organizational objectives.
- Prepare, submit and archive 510(k)s, Letters to File, EUMDR Tech Documents, Change Notifications. Respond to FDA and NB to address submission queries.
- Provide regulatory support to post-launch business maintenance activities under the guidance of Sr. RA personnel.
- 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.
Occasionally directed in several aspects of the work.
Bachelor’s degree, preferably in life sciences or related field
Desired Experience, Knowledge, and Skills:
- 2-5 years of regulatory affairs experience.
- Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
- 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.