Regulatory Affairs Specialist Job

Regulatory Affairs Specialist is needed to perform the following duties:

Regulatory affairs specialist is responsible for all aspects of regulatory processes like- To help organization meet all state, local, federal, international, and industrial regulations that apply to the products. Including FDA, EU MDR and international rules, regulations and guidance, notified body, health authorities’ guidelines, and recommendations.
· Support Regulatory activities – local, global/international regulatory strategy, submission and lifecycle maintenance across ongoing, legacy products/commercialized product, new product development (NPD), and product modifications/SRT product for Class I, Class II and Class III.
· Support U.S. FDA, EU MDR, and International/Rest of World (RoW) regulatory pathways, ensuring timely approvals and sustained market compliance.
· Support regulatory planning and execution across the full product life cycle, from early development through post-market changes and compliance maintenance.
· Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan.
· Partnered cross-functionally with representative, R&D, Design, Engineering, Manufacturing, Operation, Production, Supply chain, Supplier/Vendor, Clinical, Quality, Sterilization, Biocompatibility, Medical Affairs, IT, Software, Legal/Compliance, EH&S and Marketing to align regulatory strategies with business objectives driving efficient global product development, compliance, commercialization and lifecycle management.
· As needed - support in author/preparation 510(k) premarket notifications and supplements (including Q-Submissions, LTFs, and deficiency responses) to secure FDA clearance, and led preparation of PMAs and supplements (including clinical/non-clinical testing, risk assessments, IDE submissions) to obtain FDA approval, while managing post-approval requirements such as annual reports, change notices, and responses to FDA information.
· Support post-market compliance, including product complaint reviews, field actions, recalls, corrections/removals, annual/periodic report, complaint assessment, vigilance report, MDR reporting, and tracking of device modifications requiring new submissions.
· Author CE marking activities by preparing and maintaining comprehensive EU MDR Technical documentation - including TDRs, GSPRs checklists, DoCs, CNs, Authorized Representative (AR) verification and device registration activities in a timely and accurate manner to obtain EU MDR certification, facilitating market authorization and commercialization of products.
· Craft and deliver strategic responses to regulatory inquiries from FDA, notified bodies and health authorities through direct interaction, addressing technical and clinical submissions while ensuring alignment with regulatory expectations.
· Manage UDI/BUDI submissions to EUDAMED, including device registration, Basic UDI-DI, actor registration, and certificate modules, ensuring compliance with EU MDR requirements and supporting post-market traceability and audit readiness.

Clinical data, and post-market data collection and summarization. Discusses quantitative data analysis with team, which enable key variable analysis in clinical trial developments in real time. Presents a comprehensive overview of the management of quality assurance in clinical trials, Good Clinical Practices (GCP), and management of audit outcomes, as well as current issues and trends in the validation and auditing of clinical studies.
· Lead and Author IFUs and Harmonized Standards list (HSLs) in Windchill; Evaluated and endorsed labels, product drawings, STGs, risk management files, validation reports, CERs, CEPs, PMCF reports, PMS reports, PSURs, and SSCPs and other regulatory deliverables.
· Support sustaining activities - evaluated design, labeling, manufacturing, process changes and distribution changes for regulatory impact—determining submission pathways and preparing required filings.

Anticipate in regulatory obstacles and emerging issues throughout the products lifecycle and develop solutions with other regulatory and related teams’ members.
· Complete regulatory risk assessments and impact assessment, impact of design, labeling, manufacturing, engineering changes, process changes and supplier changes to determine regulatory pathways, support change control, guide submission strategy, and ensure regulatory compliance across product life cycles.
· Provide regulatory oversight for labeling and promotional materials, collaborating across teams to ensure compliance, timely approvals, and continuous improvement of Ad & Promo processes.
· Collaborate with cross-functional teams to support regulatory compliance with environmental regulations for waste disposal,
chemical handling, hazardous materials, or sustainability reporting.
· Contributed to ensuring product design and manufacturing processes consider company EMS
policies/environmental regulations (RoHS, REACH, WEEE in EU, or local EPA guidelines).

Write products submissions for regulatory agencies, Prepare Technical files, Design Dossier files, maintain device history files including products regulations, product development process, and clinical study documents.
· Support U.S. FDA, EU MDR, and International/Rest of World (RoW) regulatory pathways, ensuring timely approvals and sustained market compliance.
· Support regulatory planning and execution across the full product life cycle, from early development through post-market changes and compliance maintenance.
· Author CE marking activities by preparing and maintaining comprehensive EU MDR Technical documentation - including TDRs, GSPRs checklists, DoCs, CNs, Authorized Representative (AR) verification and device registration activities in a timely and accurate manner to obtain EU MDR certification, facilitating market authorization and commercialization of products.

Analyzes current product/device and maintain them per Johnson & Johnson MedTech DePuy Synthase requirements and regulatory laws. Reviews legislation and landmark, as well as laws governing formulation development, engineering design, manufacture, and commercial distribution of products.
· Support Regulatory activities – local, global/international regulatory strategy, submission and lifecycle maintenance across ongoing, legacy products/commercialized product, new product development (NPD), and product modifications/SRT product for Class I, Class II and Class III.

Integrate approach allows all decisions in the design to optimize value against both scientific and business criteria simultaneously and continuously. Integrate approach allows all decisions in the design to optimize value against both scientific and business criteria simultaneously and continuously. Work on regulatory strategy for drug delivery devices to support amendments or supplements.
· Support sustaining activities - evaluated design, labeling, manufacturing, process changes and distribution changes for regulatory impact—determining submission pathways and preparing required filings.
· Complete regulatory risk assessments and impact assessments, impact of design, labeling, manufacturing, engineering changes, process changes and supplier changes to determine regulatory pathways, support change control, guide submission strategy, and ensure regulatory compliance across product life cycles.
· Contributed to ensuring product design and manufacturing processes consider company EMS policies/environmental regulations (RoHS, REACH, WEEE in EU, or local EPA guidelines).

· Review Technical files and Design dossier files.Which includes product’s design, description and specification section – drugs and substances used in devices.

· Labeling and instruction for use.
· Prepare technical files for the Conformity assessment. Support Regulatory department and Company initiatives identified by management and support Quality Management Systems regulations (QMSR) and other regulatory requirements.
· Monitor and communicate regulatory changes to project teams, identifying potential impacts on product specifications and quality systems, and developing solutions to address complex compliance challenges, including gaps, discrepancies, and international regulatory requirements

Assure that regulatory activities are carried out within the regulatory requirements in terms of quality, operating procedures, and training to assigned and also coordinate regulatory activities from other departments. Work with Quality assurance (QA) to ensure compliance with regulations. Analyze regulatory oversight guidance Documents to ensure compliance.
· Prepare, authenticate, and route all required certificates, legal certifications, and product registration documents, ensuring strict adherence to respective local regulatory authority frameworks.
· Manage effective communication and worked with local distributors and health authority to facilitate smooth regulatory reviews and approvals within set timelines to align ongoing compliance with local statutory obligations.
· Support product release and market entry activities by reviewing and approving regulatory licenses, documentation, and release requests to ensure products were authorized for global distribution.
· Ensure compliance with FDA regulations by updating U.S. licenses and GUDID entries for exempted products.
· Maintain and update regulatory policies, procedures, and SOPs to reflect current regulatory requirements.
· Support internal and external audits and regulatory inspections by maintaining comprehensive documentation, ensuring compliance with FDA, EU MDR, MDSAP and ISO 13485 standards, and facilitating timely responses to auditor requests.

Consistently manage large amounts of changing, complex, and ambiguous information from multiple sources and make timely and effective decisions to execute project objectives. Working with project teams to select methods and techniques for obtaining desirable solutions for each project and Work collaboratively to ensure the development of Regulatory affairs practices.
· Develop and deploy regulatory strategies for submissions using the MDRIM system to maintain, track, and manage product licenses and regulatory activities for the U.S., EU, and Global/International/RoW.

Bachelor's Degree is required in Regulatory Affairs or Pharmaceutical Science or Pharmaceutics.

Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa