Regulatory Affairs Specialist II/Sr

Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, IVDD, ISO 13485, quality system auditing.

More specific responsibilities will include:

Lead and support of US 510k Submissions

Lead and support of Health Canada Device License Applications

Lead and support of International Device Licensing and Registrations

Support product development teams for new product submission requirements

Product Technical Files development and maintenance

Review and approval of ECOs related to assigned projects

Participate in Quality System Audits

Technical writing

Support UDI labeling project

Qualifications:

BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred

2+ years (Level II) or 3+ years (Sr. Level) IVD or medical device experience

Previous experience with 510k, Health Canada, International Device Submissions Licensing and Registration experience

ISO/FDA QSR, IVDD/IVDR, ISO 13485 knowledge

Excellent technical writing skills

Quality system auditing experience is preferred

Statistics and data base management proficiency preferred Certified Quality Auditor and RAC Certification are pluses.

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.