What are the responsibilities and job description for the Regulatory Affairs Specialist I position at Medical Components, Inc.?
Medical Components, Inc.Regulatory Affairs Specialist I*Local candidates preferred from the Harleysville, PA and surrounding area that can be on-site.Education and/or Experience Bachelor's degree (B. A./B.S.) from four-year college or university and/or 1 years related experience and/or training, or equivalent combination of education and experience.OrMaster’s degree (M.A./M.S.) in regulatory affairs/science and with 0 years of related experience and/or training, or equivalent combination of education and experience.RAC certification is preferred.What you will be responsible for: The Regulatory Specialist is an individual contributor to the Regulatory Department. This includes compiling documentation, providing guidance, strategy, communication, writing, and/or filing submissions to global regulatory bodies to support new product development and/or sustaining products that require regulatory approval and/or clearance. How you will contribute:
- Manages products as assigned by department management. Act as the Regulatory subject matter expert of the assigned product(s) and provide regulatory support pertaining to the product(s).
- Develop an understanding of global medical device regulations in which the organization intends to obtain marketing clearance/approval of product(s) for commercial distribution.
- Provide regulatory strategy for sustaining product projects and/or new product development project as assigned. This includes documenting testing requirements, submission/registration pathways, and anticipated approval/clearance timelines for defined target markets.
- Write complete submissions, design dossiers, technical files as required by global medical device regulations to obtain product clearances and approvals for commercial distribution within targeted selling market. Write change notifications and/or amendments to existing product clearances and/or approvals.
- Determining global Unique Device Identifier (UDI), GTINs, and GMDN codes in collaboration with Regulatory Operations Specialist.
- Compile documentation included test protocols and reports, drawings, specifications, etc. to complete a regulatory submission, registration, etc. as required by the intended global medical device regulation in which product clearance and/or approval for commercial distribution is intended. This requires cross functional departmental interaction and communication.
- Submit completed submission, registrations, application, change notification, or amendments to global regulatory authority in which clearance and/or approval for commercial distribution is intended.
- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
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