Regulatory Affairs Manager (Ridgefield Park, NJ)

Key Responsibilities :

• Oversee the day-to-day functions of the regulatory initiatives for Hiossen 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 Osstem 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 Hiossen 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.

Qualifications :

COMPENSATION & BENEFITS :

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Department / Functional Area : Marketing

Experience : years

Vacancy : 1

Monthly Salary Salary : 90000 - 120000