Job Requirements

The Regulatory Affairs Specialist provides regulatory perspective and expertise to cross-functional teams to assure products can be marketed and are compliant with relevant medical device standards, codes and regulations. S/he provides medical device regulatory input to product development, product labeling, regional specific regulatory requirements, Standards & Compliance to be followed including but not limited to product labels, Instructions for Use (IFUs), Bio Compatibility, Sterilization and submission guidelines for various regions.

S/he develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. S/he relies on ongoing experience and judgment to plan, create, develop, and maintain materials needed for regulatory compliance. S/he uses technical knowledge to drive new product submissions, listings, registration and identifying gaps in existing products in terms of revised regulatory needs. Trains and mentors cross functional team members in regulatory requirements 

Duties/Responsibilities

 

Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements.In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products in various regions and coordinates with functional team members to obtain and provide this information.Closely work with customer regulatory team in preparation of technical files and coordinates data for submission.Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications).Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling to assure regulatory compliance.Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant medical device standards, codes and regulations.Reports relevant regulation and standards changes and helps determine impact and/or appropriate action.Hands on EU-MDR, 510K, ISO14971:2019, RA Files, IFU, Regulatory submissionsDevelops an expertise of the medical device regulations for assigned products.Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information.Reports relevant regulation and standards changes, determines impact and takes appropriate action.Ensures regulatory compliance of products and processes through participation in process updates.

 

Additional Responsibilities:

Develop and maintain relationships: Build and maintain strong relationships with regulatory agencies, including the FDA, EU Notified Bodies, and other global authorities.Stay current on industry trends: Attend industry conferences, webinars, and workshops to stay informed about emerging trends, policies, and laws in the medical device industry.Provide subject matter expertise: Serve as a subject matter expert for the company, providing guidance and support on regulatory affairs matters.Collaborate with cross-functional teams: Work closely with other departments, such as quality assurance, manufacturing, and clinical affairs, to ensure a comprehensive understanding of product development and regulatory requirements.

Work Experience

Qualifications

 

Bachelor of Science in science and/or engineering field10-15 years of regulatory experience in medical device industry preferably experience working in OEMs.Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.510(k) experience and Regulatory Affairs Certification (RAC) preferred.Ability to support and execute activities related to product development teams and cross-functional projects.Ability to work well with others and manage projects.Excellent written and verbal communication skills. Proficient in Microsoft OfficeStrong understanding of technical documentation requirements for medical devices (e.g., design controls, risk management, QMS).