Regulatory Affairs Manager (Ridgefield Park, NJ)
11 days ago
Ridgefield Park
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 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: $90000-$120000, • Uncapped Commission, • $230 Biweekly Car Allowance & Gas Card, • $40 Biweekly Cellular Allowance, • Medical and Dental insurance, • Vision100% 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 vacation9 sick days);(20 days for second year), • Birthday PTO, • 11 Paid Holidays per year 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