Participate as the regulatory representative supporting cross-functional project teams.
Draft and execute regulatory strategies for new product development and device modifications, including identifying regulatory risks, tracking timelines and submission deliverables, and establishing contingency plans.
Support RA functional area in the review and approval of change orders, including writing letters to file where applicable.
Obtain market clearance and approvals for class II and III medical devices, including (but not limited) to 510(k)s, IDEs, pre-submissions and PMAs.
Create and review project deliverables for regulatory submissions.
Interact with regulatory agency authorities for initial submission and query resolution.
Review and approve device labelling and promotional materials.
Support multiple projects simultaneously.
Mentor other regulatory affairs specialists.
Support quality system changes, improvements and audits as needed.
Develop and maintain regulatory procedures.
Assist in keeping the company informed of current and proposed regulatory requirements.
Other duties as assigned.
Requirements:
Bachelor's degree required. Bachelor's degree in life sciences, engineering, or related field preferred.
Minimum of 5 years of experience in preparing US submissions for medical devices with bachelor's degree OR minimum 3 years of experience with advanced degree.
Detail oriented with well-developed writing and analytical skills.
Excellent, proven interpersonal, verbal, and written communication skills.
Experience in Microsoft Office Suite, including Word, PowerPoint, Excel.
Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
Required profile
Experience
Level of experience:Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.