Regulatory Affairs Specialist

Job Summary:

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Primary activities include coordination of regulatory compliance activities to meet 21 CFR 820, ISO 13485, MDSAP, and EU MDR regulations, organization of key regulatory submissions, and participating on projects teams to ensure new product regulatory requirements are met. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.

Duties and Responsibilities

• Write, analyze, and edit technical documents to support country- specific regulatorysubmissions and compile submissions in a format consistent with applicable guidancedocuments, including investigational device submissions in USA, South Korea, Japan, Canada,and Europe.
• Work with other departments and communicate the submission requirementswhen documents are needed for regulatory submission.
• Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc.
• Assure that appropriate maintenance of registrations occurs including renewals, devicelistings, site registrations, supplements for changes and annual reports. Support approval inother regions as required.
• Assist in preparing response to regulatory authorities' questions within assigned timelines.
• Provide risk / harm management knowledge to the relative teams (QA, UX, Development)
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Assess device related incidents/complaints for medical device reporting requirements.
• Compile and submit reportable events to relevant regulatory authorities in timely manner.
• Handle recalls and field actions, if required.
• Conduct Quarterly summary meeting for the Executive Team detailing ongoingregulatory activities, projects, incidents, and customer inquiries.
• Review and create product labels and review promotional material for compliance withapplicable regulations and technical standards.
• Support external regulatory agency audits, providing regulatory input to minimize potential
• for findings of non-compliance.
• Assist in preparing usability evaluations and clinical trial site evaluations

Education and Experience

• Bachelor's degree in related field required; degree in engineering or bioscience preferred
• 5 years of experience in a highly regulated design and manufacturing environment
• preferred
• At least 1 SaMD (software as Medical Device) Software life cycle management, product
• submission, and maintenance.
• 5 years of experience with ISO 13485, FDA Good Manufacturing Practices and regulatory
• audits preferred
• 5 years of 510(k) and Technical File preparation experience preferred
• Certifications - RAC, RAP Certifications, preferred
• Minimum of 2 years regulatory or equivalent experience within a medical device or pharmaceutical company, CRO, or similar organization
• Scientific knowledge, must be able to digest complex data while keeping the big picture through
• good analytical skills
• Excellent written and Verbal communication skills with the ability to listen, articulate and
• advocate
• Proactive, high performance, result oriented and manage projects with ethical integrity
• Technical system skills (e.g., MS office applications, databases, efficient online research)
• Manage multiple projects and deadlines
• Ability to identify compliance risks and escalate when necessary
• Demonstrate both creative and critical thinking skill

If interested, please apply or send resume confidentially to jeff.welter@gogpac.com

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.