Regulatory Affairs Specialist II

<h4>Position Summary</h4> <p>The Regulatory Affairs Specialist II supports the company’s regulatory initiatives to meet strategic short- and long-term objectives. This includes assisting with the preparation and submission of regulatory documents, maintaining compliance with applicable regulations, and supporting cross-functional teams during product development and post-market activities. The Specialist works closely with the Principal Regulatory Affairs Specialist and other team members to ensure regulatory requirements are met in a timely and compliant manner.</p> <h4>Primary Responsibilities</h4> <ul> <li>Support the development and implementation of regulatory submission strategies.</li> <li>Assist with the preparation and maintenance of US regulatory submissions, including IDEs, PMAs, and associated supplements and reports.</li> <li>Help achieve/maintain CE Marking including MDR applications, maintaining technical documentation, and associated compliance activities.</li> <li>Support review of project documentation such as risk management files, test reports, and validations for regulatory completeness.</li> <li>Assess Engineering Change Orders (ECOs) for potential regulatory impact.</li> <li>Collaborate with cross-functional teams to address questions and support responses during submission reviews.</li> <li>Assist in drafting or updating regulatory standard operating procedures (SOPs).</li> <li>Support review of promotional materials for compliance with regulatory requirements.</li> <li>Contribute to clinical trial activities and documentation in line with good clinical practice (GCP) standards.</li> <li>Support internal and external audits and other quality system activities as needed.</li> <li>Perform all duties in compliance with applicable regulations, policies, and procedures, including timely documentation and training completion.</li> <li>Bring a collaborative, solution-oriented attitude to daily work and other responsibilities as assigned.</li> </ul> <h4>Education or Certification Requirements</h4> <ul> <li>Bachelor’s degree in Scientific, Engineering, Public Health, or a related field.</li> <li>RAPs Certification preferred.</li> </ul> <h4>Professional Work Experience</h4> <ul> <li>Minimum of 3 years of direct experience in Regulatory Affairs or a related field.</li> <li>Background in medical devices, biologics, or pharmaceutical industries, medical devices preferred.</li> </ul> <h4>Qualifications and Skills</h4> <ul> <li>Strong understanding of FDA and EU regulations and guidance documents.</li> <li>Knowledge of Quality System requirements such as QSR, ISO 13485, GxP.</li> <li>Solid technical writing skills with experience preparing regulatory documentation.</li> <li>Project management skills and the ability to manage timelines within a team environment.</li> <li>Experience with software-based and/or sterile medical devices desirable but not required.</li> <li>Experience with clinical trials desirable but not required.</li> </ul> <h4>Other Essentials and Key Success Factors</h4> <ul> <li>Demonstrated ability to work independently and as part of a cross-functional team.</li> <li>Strong organizational skills with attention to detail.</li> <li>Excellent verbal and written communication skills.</li> <li>Curious, proactive, and eager to learn within a dynamic, fast-paced environment.</li> <li>High degree of professionalism, integrity, and commitment to quality.</li> </ul> <h4>Travel</h4> <p>Minimal travel required.</p> <p> </p> <h4>Compensation</h4> <p>This position offers a competitive salary in the range of $115,000 – $150,000 annually, along with a comprehensive benefits package. Actual compensation will be based on relevant experience, education, and market factors.</p> <p> </p> <p><strong>In accordance with Massachusetts law, General Laws Chapter 149, Section 19B. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.</strong></p> <h4> </h4> <p> </p> <section class="b_paragraph" data-md-index="7" data-bm="101"></section> <section class="b_paragraph" data-md-index="8" data-bm="102"></section>