Regulatory Affairs Specialist - Post Market

The Post-Market Regulatory Affairs Specialist represents the Regulatory Affairs function and is responsible for knowledge of requirements and processes for maintaining a product in the clinical setting, including reporting and surveillance. Reporting to the Director of Regulatory Affairs, this position is also responsible for supporting recordkeeping, monitoring, regulatory notifications, adverse event evaluation, and change management. Duties &

Responsibilities: Primary Needs/

Responsibilities: • A strong candidate must have Medical Device IDE (clinical trial) experience and understands the FDA expectations for design changes to the medical device and, thereby with understanding of this need, this individual contributor assesses the potential impact of the changes to the product being used in clinical study and collaborates with Leadership in Quality, Medical Affairs, Engineering team on exploratory pathways and options as next steps.

• Responsible for Medical Device Reporting, preparing FDA-Form 3500A, on a case-by-case basis. • Represent Regulatory Affairs function in the Product Issue Review Board meeting • Support Quality Systems projects and activities such as, but not limited to, the following: • Complaint Handling • Product Recalls and Corrections • Product adverse event reporting • Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders Secondary

Responsibilities: • Any required support for pre-market regulatory responsibilities, such as, evaluation of changes from impact perspective, and compliance checks.

Qualification Requirements: • A minimum BA/BS Degree with at least 3-5 years of regulatory affairs experience required in medical device industry. • Certification in regulatory affairs (RAC) preferred. Experience and

Required Skills: • Experience with medical device IDE trials is required. • Post-Market medical device regulatory experience required. • Broad based technical awareness and exposure to functions such as Engineering, Operations, Quality, Marketing, Medical/Clinical Affairs, etc. Knowledge & Abilities: • General working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.

• Good knowledge of Clinical evaluation and investigation of medical devices. • Excellent interpersonal skills including ability to interact with high degree of diplomacy. • Excellent problem-solving skills, applied thinking skills and technical writing skills. • Excellent communication and organization skills required. • Ability to work in a fast-paced, technically challenging environment where drive is critical to success. A self-starter who is able to drive projects, can assertively outline regulatory risks to cross-functional team, and has a "roll up sleeves" positive attitude.

• Strong preference for a well-rounded person with experience in a start-up medical device environment with a combination of regulatory and clinical skill set. • Expertise in bolthires Office applications, such as MS Word and Excel. Physical Demands: • Prolonged periods of sitting at a desk and working on a computer. • Must be able to lift 15 pounds at times. Working Environment: • Office or work-station environment (at least 3 times/week in office). Travel: • No travel required EOE Statement: Specialist Staffing Group is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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