Regulatory Affairs Specialist

United States | Scott Zawko | Full-time | Fully remote

Apply

Full-time

We are looking for a Regulatory Affairs Specialist to join our team.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s regulatory service offerings and supporting clients on a portfolio of two to three projects covering regulatory, engineering, and compliance challenges related to medical devices, drug products, and combination products. The Regulatory Affairs Specialist will work under the guidance of Kymanox management and with support of multiple experienced technical project managers as well as work closely with clients at their offices.

Projects may include the following focus areas:

· Regulatory Submission Authorship and Review

· Device/Drug/Combination Product Development and Commercialization

· Design Controls and Design Change Management

· Quality Risk Management

· Technical Report Authorship and Review

· Quality Management Systems (QMS) Support

· Auditing and gap assessments of QMS/DHF/RMF/technical documentation

Responsibilities

· Prepare US regulatory submissions (IND/NDA/510k/PMA/technical documentation/drug dossier) and annual reports for regulatory authorities

· Perform technical and regulatory review of source documents

· Review and edit dossiers, briefing books, and responses to health authority questions; work with SMEs and authors to prepare information for submissions and ensure submission readiness

· Participate in product development teams as regulatory SME

· Conduct audits/gap assessments of quality system documentation, regulatory submissions, design history files, risk management files, and technical documentation against industry regulations and standards (US/EU/ROW)

· Directly support and provide subject matter expertise related to all disciplines of Regulatory but not limited to complaints handling and adverse event reporting, design controls, risk management, and quality management systems

· Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations

· Author and review gap assessment reports, audit reports, SOPs, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice

· Compile and review information relating to regulatory submissions, inspections, or response letters to regulatory bodies

· Review combination product development process documentation including user requirements, technical design requirements, product risk management (including user FMEA, risk management reports)

documents, verification and validation test protocols; and communicate any regulatory-specific red flags during review

· Provide assessment of regulatory impact of changes to on market products

Educational Background

· Bachelor’s or Master’s degree in regulatory affairs or science-related discipline or engineering from an accredited institution

· Industry certifications (e.g., RAC, ASQ) preferred.

Experience

· 2-4 years regulatory experience in the US medical device, pharmaceutical, or combination products industry

Desired Aptitude and Skill Set

· Demonstrated experience of preparing FDA submissions (IND/NDA/IDE/510(k)/PMA)

· Working knowledge of Quality System requirements (FDA Part 820, Parts 210/211, Part 4, and ISO 13485)

· Working knowledge of design controls (FDA 21 CFR 820.30)

· Working knowledge of device risk management (ISO 14971)

· Working knowledge of EU medical device requirements (MDD and MDR) preferred

· Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision

· Highly organized

· Resourceful, Self-directing, self-pacing, fast learner

· Excellent analytical and communication skills, particularly writing skills, are essential

· Pleasant and positive communication style

 

Travel: 

Local travel within the assigned region and surrounding areas is required.  Up to 30% domestic and international travel may be required from time to time.  The intent of this position is to stay local in the assigned region; however, the best project and growth opportunities may require initial travel to establish yourself and/or the firm with the client.  If not located near Kymanox Headquarters, quarterly visits to RTP, North Carolina are expected.

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and New Jersey.