Here at SRG, we partner with a global medical technology company that designs and manufacturers medical technology in a range of therapy areas. They are looking for a Senior Regulatory Affairs Specialist to join their wound care business.
As the Senior Regulatory Affairs Specialist, you will be responsible for providing regulatory expertise in the research, development, and marketing of Wound Management products and to ensuring that regulatory approvals are obtained and maintained in accordance with the agreed registration programme and the needs of the business plans.
Some of your main duties and responsibilities include:
- To compile, review and approve, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications.
- To complete the requirements of the agreed regional program as agreed with the Commercial teams.
- To complete the requirements of the Registration Programme as agreed with the AWM and Operations departments.
- To provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
- In relation to the above, to interpret individual country legislation relevant to the company's AWM business.
- To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
- To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
- To review and approve change control impact assessments for products.
- To approve European Technical Files and regulatory despatches, where appropriate.
- Deputise for the Regulatory Affairs Managers and the Regulatory Affairs Director when required.
- Ensure compliance to cGMP, cGDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.
- To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.As the ideal candidate, you will be educated to degree level in a clinical, medical, or scientific/technical field. You will have medical device industry experience, working within a regulatory role (3-5 years minimum). You will have extensive knowledge of US FDA, EU MDR and international laws, regulations, and guidelines. Experience with wound medical devices is advantageous.
As the ideal candidate, you will be educated to degree level in a clinical, medical, or scientific/technical field. You will have medical device industry experience, working within a regulatory role (3-5 years minimum). You will have extensive knowledge of US FDA, EU MDR and international laws, regulations, and guidelines. Experience with wound medical devices is advantageous.
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