Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions.
- Develop regulatory strategies for new, existing, and modified medical devices and other regulated products.
- Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions.
- Coordinate with the team to monitor the progress of certain products submitted by Ostend Regulatory Affairs departments.
- Collaborate with business partners for global registrations to ensure compliance.
- Lead and manage regulatory submissions, including 510(k) submissions and technical files for CE marking.
- Handle communications with the FDA and EU notified bodies regarding FDA pre-submissions, FDA 510(k) submissions, and EU technical files submissions.
- Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle.
- Review and interpret regulatory requirements and guidance documents to ensure compliance.
- Coordinate regulatory activities with internal teams and external regulatory agencies.
- Review and approve product labeling and claims for the US and EU markets.
- Stay current with regulatory requirements and update affected policies and procedures.
- Manage the day-to-day activities of less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, development plans, and succession planning.
- Comply with company and departmental policies and administrative requirements.
- Perform other duties as assigned or needed.
- Actively articulate and promote Hassen vision and direction.
- Advocate on behalf of the customer.
- Promote high performance, innovation, and continual improvement.
- Consistently meet Company standards, ethics, and compliance requirements.
- Resolve conflicts and foster a positive working environment.
- Bachelor's degree in life sciences, regulatory affairs, or a related discipline.
- Minimum of 5 years of experience in regulatory affairs, preferably in the medical device industry.
- Proven experience in leading regulatory submissions and managing regulatory projects.
- In-depth knowledge of FDA 510(k) and international regulations, including EN ISO 13485 and EU MDR.
- Proficiency with Microsoft Office Suite and regulatory software.
- Strong leadership, project management, and organizational skills with attention to detail.
- Excellent written and verbal communication skills
- Prior technical writing experience and a proven track record with FDA and EU regulatory submissions.
- Excellent interpersonal skills and ability to work effectively both in a team environment and independently.
- Solid understanding of regulatory affairs principles and practices.
- Ability to review and assess detailed scientific information critically.
- Willingness to learn and adapt to new processes and technologies.
- Demonstrated leadership experience with medical device organizations.
- Strong results orientation and analytical skills.
Source : Katalyst Healthcares & Life Sciences
