SENIOR REGULATORY AFFAIRS INTERNATIONAL SPECIALIST
Providence, RI 02910
Location: Providence, RI
Company: Top Medical Equipment / Devices
Compensation: $80K-$110K Base + Bonus + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
Interventional Surgery worldwide business unit is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. This company is the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products. The BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties. The company has a strong tradition of developing our employees to learn, grow and excel.
This position is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers (IBCs). This position entails development of submissions in conjunction with other Interventional Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents.
1.Bachelor's degree required, with an understanding of healthcare industry.
2.Minimum 5-7 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers) and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific).
3.Experience working with international businesses or cultures.
4.Good oral and written communication skills - ability to work on cross-functional teams.
5.Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
6.Working knowledge of electronic documentation and information systems.