Accelerating Medical Innovation
To Enhance Patient Wellbeing
Regulatory Affairs Specialist II
Regulatory Affairs Specialist II
As Regulatory Affairs Specialist II, you will be responsible for preparing US and International regulatory submissions. You will be responsible for development, maintenance, and review of submissions, documentation, labelling, and procedures. This position will be responsible to manage post-market surveillance complaint information for PBC Inc medical devices.
The role will involve
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Maintain the company’s medical device listing and device & tissue establishment registrations
- Work with Quality Assurance Team on audits, complaint investigations, NCRs, CAPAs, medical device reporting, and recalls.
- Prepare domestic and international regulatory submissions, additional information request responses, and renewals
- Provide regulatory input for product recalls and recall communications
- Report adverse events to regulatory agencies and internal stakeholders
- Ensure compliance with product post marketing approval requirements
- Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Review and approve labelling, promotional materials, and publications to ensure compliance with FDA and international requirements.
- Maintain compliance of distribution control database
- Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
- Write and revise department standard operating procedures (SOP’s)
- Review and approve engineering change requests for design, manufacturing, and labelling changes to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries
- Assist senior regulatory staff with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities.
- Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that regulatory submissions meet the company’s product launch timelines in all identified markets.
- Participate in new-hire employee selection process
- Mentor new hires as requested by management
- Perform other administrative tasks, as necessary (e.g., filing, spreadsheet management, etc.)
- Perform other tasks as assigned by management (e.g., due diligence, etc.)
Role and Responsibilities
- Specific duties associated with client services are specified in client contracts/service agreements.
- Perform assigned services in accordance with specified client/PBC BioMed procedures.
- Ensure protection of client confidential information in accordance with Non-Disclosure Agreements.
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on the established timelines for new product launches and other projects.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Qualifications and Education Requirements
- Minimum 2 years’ experience in the regulatory field in a regulated industry
- Experience with medical devices, orthopaedics preferred
- Extensive knowledge of FDA medical device regulations such as 21 CFR Parts 803, 806, 807 and 820, and applicable international regulations and standards required
Required Skills, Knowledge and Abilities
- Basic knowledge of FDA and applicable international regulations, preferred
- Experience within post marketing activities such as adverse event reporting and recalls
- Ability to work independently and/or with guidance from management to perform job functions
- Ability to read, analyse, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
- Ability to write detailed technical regulatory submissions, reports, and business correspondence
- Ability to effectively present information to other employees, management, and regulatory agencies
- Documented evidence of proficient written and verbal communication skills
- Excellent interpersonal skills
- Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities
- Computer skills, including Microsoft Office Suite and Microsoft Outlook
- Ability to work well in a cross-functional setting