Regulatory Affairs Manager (Bilingual in Koran and English) - Ridgefield Park, NJ

Hiossen•Ridgefield Park, NJ

10d•$90,000 - $120,000

About The Position

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.

Requirements

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.
Proficient Microsoft Excel, PowerPoint & Word
Bilingual in Korean and English required (for communication with the parent company, Osstem, in South Korea)

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.

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