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:

• 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.

Benefits:

• Health, vision, and dental insurance
• 100% company paid life insurance, long- and short-term disability
• 401(k) with 100% company match (up to 5% of salary)
• PTO (15 days for first year-[6 days paid vacation,9 sick days]);(20 days for second year)
• 9 paid holidays

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)