Job Description
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA.
Regulatory Affairs Specialist II is a growth opportunity for individuals with some experience, who are eager to advance in the regulatory affairs profession. Regulatory Affairs Specialist II provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. In addition, at this level, the role will lead departmental projects.
Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. Nova is the largest privately owned IVD company in the U.S. with over 1,200 employees globally. Our eight percent compounded annual growth over nearly a decade is more than double the IVD market growth, making Nova one the fastest growing IVD companies in the world.
Essential Responsibilities And Accountabilities - Lead and Support US 510K Submissions.
- Lead and Support Health Canada Device License Applications.
- Lead and Support Self Certified and Notified Body Reviewed EU Technical File Preparation.
- Lead regulatory affairs departmental projects.
- Support International Device Licensing and Registrations.
- Support Product Development Teams for New Product Submission Requirements.
- Participate in, and support internal and external Quality System Audits.
- Produce Technical Writing.
- Coordinate Departmental activities for International Device Licensing and Registrations
- Leads, participate in, and support Internal and External Quality System Audits
Qualifications - Experience with international product registrations
- Experience authoring 5 10k submissions
- Experience authoring FDA Q-submissions
- Experience with Class Il and Class Ill Health Canada license applications
- Experience with Class B and Class C IVDR submissions
- Experience supporting ISO: 13485 and MDSAP audits
- Experience reviewing and assessing design changes for regulatory impact
- Experience working with R&D teams and providing input during the product development cycle
- Experience reviewing and creating labelling to ensure compliance with US and International Regulatory Requirements
- Problem solving and communication skills a must
- Quality system auditing experience is preferred
Skills And Competencies - Excellent technical writing skills
- Ability to lead multiple projects through inception through to completion.
- Statistics and database management proficiency
Education - BS Degree in the Sciences, or equivalent
- MS in Regulatory Affairs is preferred
At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.
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