Will have a broad spectrum of responsibilities spanning from participation in label review, product development teams and preparation of global regulatory submissions.
Essential Duties and Responsibilities
- Prepare and maintain Technical Files in support of global submissions.
- Prepare and submit submissions to obtain global approval.
- Review labeling and labels for compliance with regulatory requirements.
- Review, assess and provide input to Change Orders; assessing the requirements for regulatory submissions.
- Participate and provide Regulatory strategy in product Design Control teams.
- Prepare and submit annual reports and license renewals to the FDA and other International regulatory agencies, including coordinating and managing a multi-disciplinary team assigned to provide technical input and expertise for sections of the reports.
- Provide regulatory input for ways in which to position a product or a change to an existing product in order to gain regulatory approval in country (ies) for company commercialization.
- Review, assess and provide input into Standard Operating Procedures (SOPs) to ensure regulatory compliance.
- Manage regulatory files/database and chronologies.
- Support product complaint investigations.
- Bachelor’s Degree
- 7-9 years’ experience within the Regulatory Affairs discipline and/or training; or an equivalent combination of education and experience
- Proven ability to successfully manage multiple projects in a dynamic environment.
- Willingness to “roll up sleeves” to perform at all levels and assist in areas outside of core responsibilities.
- Strong strategic thinking and analytical skills.
- Experience with Class III devices strongly desired.
- International regulatory experience is a plus.
Please send resume to firstname.lastname@example.org and reference Senior Regulatory Affairs Specialist in the subject line.