Job Description

Are you a Regulatory Affairs Specialist with in vitro diagnostic experience looking for a new contract role in the Franklin, MA area? This individual will serve as a subject matter expert for planning, coordinating, and implementing regulatory strategies for products requiring domestic and/or international governmental approval. Coordinate, support, and author clear and concise regulatory filings and responses for both domestic and international product registrations for in vitro diagnostic medical devices. Provides regulatory support on a range of activities which include domestic/international submissions, change assessments, quality system support, post market surveillance, and other compliance activities.

Responsibilities

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents for in vitro medical devices globally (i.e. FDA, ISO, EU, IVDR, TGA, etc.)
• Collaborate effectively with project teams company wide, peers, and customers to obtain and understand registration requirements and identify solutions with regards to regulatory strategies.
• Coordinate, support, and author clear and concise regulatory filings for both domestic and international product registrations for in vitro diagnostic medical devices. Duties include writing, formatting, compiling and maintaining supporting documentation/technical files for new products and product modifications.
• Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, or clarification and follow-up of regulatory filings or submissions under review.
• Prepare technical information for specific customer/distributor or authorized representative requests to support global product registration (e.g. MDSAP for U.S., Australia, Canada, Brazil, and Japan).
• Participate in design control for products including review of design documentation, design changes, and update technical files as needed.
• Identify, obtain, and maintain relevant guidance documents, international standards, or consensus standards and complete gap analysis on new or updated regulations and standards to ascertain regulatory impact and recommend changes to ensure compliance.
• Perform Post Market Surveillance activities and review Post Market Surveillance data for regulatory compliance and reporting requirements.
• Investigate regulatory history of similar products as part of biannual Management Reviews.
• Collaborate effectively with project teams to identify risks and risk mitigation strategies.
• Write or update SOPs related to the regulatory affairs responsibilities and actions.
• Review product labeling, including promotional material, marketing literature, and the company website for compliance with applicable regulations.
• Participate in systematic review of SOPs to ensure accuracy and compliance.
• Maintain up to date file of documents of external origin.
• Maintain records of all regulatory filings and communications.
• Interview prospective employees.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree in Biochemistry, Microbiology, or related field
• 1 or more years of previous related experience
• Basic knowledge of US, ISO, and European regulations for in vitro diagnostics.
• Ability to work independently with minimum supervision.
• Good communication skills, both verbal and written reports.
• Effective project management and problem-solving skills.
• Good organizational ability and strong attention to detail.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
• Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization

Location

• Franklin, MA

Employment Type

• Contract

Working Conditions

Control exposures to hazardous chemicals & other safety hazards such as:

• Carcinogens.
• Strong and obnoxious fumes.
• Sharp and dangerous blades and needles.
• Biohazard exposure to specimens.

Compensation and Benefits

• $50 to $60/hr. depending on experience.
• Choice of medical, dental, and vision plans
• Paid vacation time
• 401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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