Regulatory Affairs Manager (Ridgefield Park, NJ)Hiossen • Ridgefield Park, New Jersey, USA
Regulatory Affairs Manager (Ridgefield Park, NJ)
Hiossen • Ridgefield Park, New Jersey, USA
12 days ago
Job type
- Full-time
Job descriptionBachelors 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. 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
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 :
COMPENSATION & BENEFITS :
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
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