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Regulatory Affairs Manager - Medical Device
Competitive compensation package
OEM Medical Device company; player/coach type of role
About Our Client
Responsible for managing and leading personnel who maintain the assigned FDA and international regulatory files and prepare submissions in support of product registrations, including 510(k)'s, technical files and international product registrations. Work with project team to identify regulatory requirements and assure labeling is in compliance with regulatory requirements, and following company policies and procedures.
- Provides regulatory support to project teams in accordance with regulatory requirements and following company policies and procedures.
- Create and maintain technical files and other records.
- Provide timely review and approval of product labeling for regulatory compliance.
- Prepare and submit 510(k)'s and international product registration documents.
- Provide training to company procedures to employees.
- Perform other related duties as assigned by management.
- Develop and approve assigned regulatory strategies for new products and design changes.
The Successful Applicant
- Five years in a quality system or medical device industry with computer training.
- Four year degree in an engineering discipline or equivalent.
- Provide direction and leadership to assigned regulatory affairs personnel.
What's on Offer
- Player/Coach opportunity
- Great team culture and collaborative work environment
- Competitive compensation package