Planet Pharma
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Regulatory Affairs Specialist
3401 Masons Mill Rd Bryn Athyn, PA 19009 US
Posted: 04/21/2023
2023-04-21
2023-07-03
Employment Type:
Direct Hire/Perm
Job Number: 554489
Is job remote?: No
Country: United States
Job Description
Summary
The Regulatory Affairs Specialist will act as the subject matter expert for US and Canadian In-Vitro Diagnostics/ medical device regulations. The role is responsible for the preparation of regulatory submissions of marketing approvals and amendments required for the distribution of Medical Device/IVD products domestically and globally, in conjunction with marketing forecasts and plans. This role will also be responsible for supporting the review of IVD labeling subject to regulatory control. The responsibility includes compliance with procedures aligned with product development and change control processes in order to address regulatory requirements and business objectives. The Regulatory Affairs Specialist will interact with distributors and regulatory counterparts worldwide. This role will report to the Regulatory Affairs Manager.
Essential Functions • Responsible for compiling documents required for FDA submissions (e.g. 510(k)s, IDE, Pre-subs);
• Responsible for compiling documents required for technical files, design dossiers and other international product registration submissions including (BNLT) Europe, Canada;
• Interact with partners and distributors throughout the world to ensure assistance and cooperation on regulatory issues including licensing, registrations, post-market issues/reports, new & emerging regulatory requirements, recalls, withdrawals, and notifications;
• Interact with global regulatory counterparts and regulatory authorities on issues relating to submissions, approvals or clearance of the company’s IVD devices, as needed;
• Ensure timely submission of licenses and applications to authorities, adhering to deadlines;
• Work with project teams to ensure that the company's products (new and modified) comply with domestic and international regulations for areas the products are intended for distribution;
• Review, advise and recommend changes to product labelling to ensure regulatory compliance (including UDI);
• Coordinate the implementation of updated product labeling with cross-functional teams;
• Maintain current knowledge of U.S. and international medical device and in vitro diagnostic device (FDA, IVD, IVDR, CAN) regulatory requirements;
• Work with the RA Manager to write clear justifications and explanations for new product licenses, regulatory impact assessment, and license renewals;
• Facilitate generating and issuing Certificates of Foreign Government (CFG’s);
• Help maintain the company’s quality system and procedures to reflect current requirements and state-of-the-art;
• Assist/support/participate, as appropriate, with regulatory inspections and third-party audits;
• Performs other duties and tasks as assigned by management.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
General Competencies: • Ability to work independently or in group setting is required
• Ability to effectively communicate both verbally and in writing is required
• Strong interpersonal skills with internal and external customers is required
• Ability to organize information and present to a wide array of audiences
• Ability to work with specialized computer software is required
Travel
This position may require infrequent travel, domestically and/or internationally.
Required Education and Experience • Bachelor’s degree in a technical field, preferably Regulatory Affairs
• 3 years of experience in regulatory affairs for the medical device or pharmaceutical industry.
• Working knowledge of Good Manufacturing Practices (GMPs)
• Prior experience in compiling information for clearance/approval within FDA and ISO guidelines.
• Ability to operate a computer and basic Office software
Desirable Education and Experience • RA certificate, degree, RAC or regulatory affairs experience
• Working knowledge / prior experience in US and International registration and marketing approval processes for IVD products
• Working knowledge / prior experience of applicable EU directives and ISO standards for IVD devices
• Familiarity with research-use-only (RUO) applications, and LDT’s
• Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required)
• Project management experience
Salary Range: $95-110k
The Regulatory Affairs Specialist will act as the subject matter expert for US and Canadian In-Vitro Diagnostics/ medical device regulations. The role is responsible for the preparation of regulatory submissions of marketing approvals and amendments required for the distribution of Medical Device/IVD products domestically and globally, in conjunction with marketing forecasts and plans. This role will also be responsible for supporting the review of IVD labeling subject to regulatory control. The responsibility includes compliance with procedures aligned with product development and change control processes in order to address regulatory requirements and business objectives. The Regulatory Affairs Specialist will interact with distributors and regulatory counterparts worldwide. This role will report to the Regulatory Affairs Manager.
Essential Functions • Responsible for compiling documents required for FDA submissions (e.g. 510(k)s, IDE, Pre-subs);
• Responsible for compiling documents required for technical files, design dossiers and other international product registration submissions including (BNLT) Europe, Canada;
• Interact with partners and distributors throughout the world to ensure assistance and cooperation on regulatory issues including licensing, registrations, post-market issues/reports, new & emerging regulatory requirements, recalls, withdrawals, and notifications;
• Interact with global regulatory counterparts and regulatory authorities on issues relating to submissions, approvals or clearance of the company’s IVD devices, as needed;
• Ensure timely submission of licenses and applications to authorities, adhering to deadlines;
• Work with project teams to ensure that the company's products (new and modified) comply with domestic and international regulations for areas the products are intended for distribution;
• Review, advise and recommend changes to product labelling to ensure regulatory compliance (including UDI);
• Coordinate the implementation of updated product labeling with cross-functional teams;
• Maintain current knowledge of U.S. and international medical device and in vitro diagnostic device (FDA, IVD, IVDR, CAN) regulatory requirements;
• Work with the RA Manager to write clear justifications and explanations for new product licenses, regulatory impact assessment, and license renewals;
• Facilitate generating and issuing Certificates of Foreign Government (CFG’s);
• Help maintain the company’s quality system and procedures to reflect current requirements and state-of-the-art;
• Assist/support/participate, as appropriate, with regulatory inspections and third-party audits;
• Performs other duties and tasks as assigned by management.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
General Competencies: • Ability to work independently or in group setting is required
• Ability to effectively communicate both verbally and in writing is required
• Strong interpersonal skills with internal and external customers is required
• Ability to organize information and present to a wide array of audiences
• Ability to work with specialized computer software is required
Travel
This position may require infrequent travel, domestically and/or internationally.
Required Education and Experience • Bachelor’s degree in a technical field, preferably Regulatory Affairs
• 3 years of experience in regulatory affairs for the medical device or pharmaceutical industry.
• Working knowledge of Good Manufacturing Practices (GMPs)
• Prior experience in compiling information for clearance/approval within FDA and ISO guidelines.
• Ability to operate a computer and basic Office software
Desirable Education and Experience • RA certificate, degree, RAC or regulatory affairs experience
• Working knowledge / prior experience in US and International registration and marketing approval processes for IVD products
• Working knowledge / prior experience of applicable EU directives and ISO standards for IVD devices
• Familiarity with research-use-only (RUO) applications, and LDT’s
• Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required)
• Project management experience
Salary Range: $95-110k
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