Regulatory Affairs Manager

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.

COMPENSATION & BENEFITS:

• Salary: $90,000-$120,000
• Uncapped Commission
• $230 Biweekly Car Allowance & Gas Card
• $40 Biweekly Cellular Allowance
• Medical and Dental insurance
• Vision,100% Company sponsored
• Basic Life Insurance and AD&D, 100% Company sponsored
• Short Term and Long Term Disability Insurance, 100% Company sponsored
• 401(k) plan with a company match up to 5%
• PTO (15 days for first year-[6 days paid vacation,9 sick days]);(20 days for second year)
• Birthday PTO
• 11 Paid Holidays per year

Salary : $90,000 - $120,000