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

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:Bachelors 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 skillsPrior 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.OTHER SKILLS/LICENCE:Proficient Microsoft Excel PowerPoint & WordBilingual in Korean and English required (for communication with the parent company Osstem in South Korea)COMPENSATION & BENEFITS:Salary: $90000-$120000Uncapped Commission$230 Biweekly Car Allowance & Gas Card$40 Biweekly Cellular AllowanceMedical and Dental insuranceVision100% Company sponsoredBasic Life Insurance and AD&D 100% Company sponsoredShort Term and Long Term Disability Insurance 100% Company sponsored401(k) plan with a company match up to 5%PTO (15 days for first year-6 days paid vacation9 sick days);(20 days for second year)Birthday PTO11 Paid Holidays per yearRequired 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