Katalyst CRO
Overview
Regulatory Affairs Consultant role at Katalyst CRO. Responsibilities
Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of product registrations. Participate on product development teams, providing regulatory strategies, timelines, and direction. Review and approve technical documentation. Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle. Drive product change assessments and define regulatory impact of product changes in global markets. Review and approve labeling, training, promotional, and advertising material. Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Participate on audit and field action teams and support other post-market activities. Facilitate and prepare U.S. regulatory Pre-Submission documents and pre-submission meetings. Provide regulatory leadership for IVDR activities; collaborate with regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance. Prepare documents vital for new product market clearance, approval, and continuation during product lifecycle management (including, but not limited to) 510(k)s, PMA, De Novo, and technical files for CE marking. Support global regulatory registration representatives for product global registration activities. Keep abreast of new or revised regulations, guidelines, compliance guides, inspection reports, journals, meetings, etc. Conduct trainings and/or communicate appropriate materials to enhance the team's knowledge of working in a regulated environment. Assist Regulatory department in updating, improving, and creating internal policies and procedures. Participate in business meetings with external partners as needed. Participate in inspections/audits by notified bodies or other international regulatory bodies by producing requested documents or answering inquiries for information. Requirements
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Minimum of 5 years of IVD Regulatory Affairs experience, including 510(k), De Novo, PMA, PMA supplement submissions. Experience as the RA representative on project core teams providing regulatory guidance and RA strategies. Excellent knowledge of U.S. and European/International regulations and standards. RAPS Regulatory Affairs Certification (RAC). Experience interacting with FDA and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Business Consulting and Services
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Regulatory Affairs Consultant role at Katalyst CRO. Responsibilities
Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of product registrations. Participate on product development teams, providing regulatory strategies, timelines, and direction. Review and approve technical documentation. Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle. Drive product change assessments and define regulatory impact of product changes in global markets. Review and approve labeling, training, promotional, and advertising material. Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Participate on audit and field action teams and support other post-market activities. Facilitate and prepare U.S. regulatory Pre-Submission documents and pre-submission meetings. Provide regulatory leadership for IVDR activities; collaborate with regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance. Prepare documents vital for new product market clearance, approval, and continuation during product lifecycle management (including, but not limited to) 510(k)s, PMA, De Novo, and technical files for CE marking. Support global regulatory registration representatives for product global registration activities. Keep abreast of new or revised regulations, guidelines, compliance guides, inspection reports, journals, meetings, etc. Conduct trainings and/or communicate appropriate materials to enhance the team's knowledge of working in a regulated environment. Assist Regulatory department in updating, improving, and creating internal policies and procedures. Participate in business meetings with external partners as needed. Participate in inspections/audits by notified bodies or other international regulatory bodies by producing requested documents or answering inquiries for information. Requirements
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Minimum of 5 years of IVD Regulatory Affairs experience, including 510(k), De Novo, PMA, PMA supplement submissions. Experience as the RA representative on project core teams providing regulatory guidance and RA strategies. Excellent knowledge of U.S. and European/International regulations and standards. RAPS Regulatory Affairs Certification (RAC). Experience interacting with FDA and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Business Consulting and Services
#J-18808-Ljbffr