What are the responsibilities and job description for the Regulatory Affairs Specialist position at Innovative Health LLC?

Job Description

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for pre-market submissions (i.e., FDA 510(k) submissions, Health Canada Medical Device License Applications) and documentation for other international regulatory bodies. This role also supports post-market regulatory compliance activities.

Essential Duties and Responsibilities :

Write and lead the completion of high quality pre-market submissions;
Review and verify documents / technical information for regulatory submissions from various functional areas and check for errors, legibility, and missing information;
Review and approve protocols and reports to support regulatory submissions;
Prepare or assist with preparation of additional information or responses as requested by regulatory agencies;
Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects;
Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;
Conduct regulatory review and approval of change orders, CAPA / nonconformance, and related project documentation;
Review labeling and promotional material to ensure compliance with applicable regulations and policies;
Implement and maintain unique identifier (UDI) activities for compliance;
Assist with PFMEA risk assessments;
Review complaints / adverse events for assessment of reportability and submission of MDRs if appropriate;
Assist in archiving regulatory documentation and maintaining related databases;
Participate in internal and external audits;
Write or update standard operating procedures, work instructions or policies;
Assist with coordinating recall or market withdrawal activities as necessary;
Other duties as assigned.

Supervisory Responsibilities :

None

Education, Qualifications and Skills :

Minimum of Bachelor's degree (preferably in technical field (i.e. engineering, medical)) or equivalent education, training and experience;

Minimum of three (3) years medical device regulatory and / or quality experience;

Knowledge and experience of FDA 21 CFR Part 820, and 510(k) submission requirements;

Knowledge of Canadian Medical Device Regulations, MDD, MDSAP, ISO standards and filing regulatory submissions with Health Canada preferred;

Detail oriented, with emphasis on accuracy and completeness;

Strong critical thinking skills;

Excellent organization, written and verbal communication skills;

Ability to work in a fast paced / entrepreneurial team environment;

Ability to work with changing priorities that involve multiple and concurrent projects;

Ability to write technical documents (i.e procedures);

Ability to recommend technical solutions;

Ability to specify regulatory requirements for products;

Ability to work with little supervision;

Self-starter and highly motivated;

Ability to use personal computers including software such as : Word, PowerPoint, Excel, Project and Minitab.

Work Environment :

This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit; stand; walk; use hands and arms.

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and / or move up to 20 pounds.

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Regulatory Affairs Specialist

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