Regulatory Affairs Specialist

Regulatory Affairs Expert We are seeking a seasoned professional to manage our legal and regulatory affairs. The successful candidate will be responsible for providing expert advice on commercial agreements, contract negotiation, and compliance with relevant regulations. Key Responsibilities: Advise on commercial agreements, including third-party contracts,...

**Job Overview:**We are seeking a seasoned Regulatory Affairs expert with expertise in pharmaceutical and medical device regulatory compliance.The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Key...

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...

We are seeking a highly skilled professional to join our client in the Medical Device Industry.Job Description:Quality Assurance and Regulatory AffairsEnsure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Coordinate with regulatory authorities for obtaining required permissions and approvals.Oversee risk management, clinical evaluation,...

Business Compliance SpecialistKey Responsibilities:Assist clients with business entity formations, including LLCs, corporations, partnerships and sole proprietorships.Manage federal business registrations, including obtaining Employer Identification Numbers (EIN), IRS filings, and compliance.Conduct state-specific registrations, including sales tax,...

Compliance Specialist - BIS CertificationWe are seeking a skilled Compliance Specialist to assist our clients in obtaining the ISI Mark Scheme certification under the Bureau of Indian Standards (BIS). The specialist will play a key role in ensuring compliance with BIS standards for manufacturers and importers of products.Our goal is to help clients navigate...

**Compliance Officer Role Overview**The Compliance Officer is a crucial position within the organization, responsible for ensuring adherence to regulatory standards and maintaining accurate records. This role plays a vital part in safeguarding the welfare of children and upholding high facility standards.**Job Responsibilities:**Conduct regular child...

Job Overview:This role requires a professional with experience in ensuring compliance and liaison with regulatory bodies, effective communication between departments and thorough understanding of local authorities to drive smooth plant operations.Key Responsibilities:Evaluate and maintain manufacturing plant compliance with local, state and federal...

Senior Medical Devices Engineer OpportunityWe are seeking a highly skilled Senior Medical Devices Engineer with extensive experience in quality management, regulatory affairs, and risk management to lead our medical devices team. This is an exciting opportunity for a professional to develop and implement quality management systems, ensuring compliance with...

Compliance Leadership RoleWe seek a seasoned professional to fill this Compliance Leadership position. The ideal candidate will have extensive experience in compliance and corporate governance, adhering to all relevant laws and regulations.Main Responsibilities:Advise the board of directors on corporate governance matters, ensuring efficient...