Regulatory Affairs Specialist

Regulatory Affairs Specialist
Location: Marlborough, Massachusetts

Do you have a proven track record of working with Regulations and the implementation of labeling for Medical Device UDI project? Do you want to work on a fantastic team as they undergo the changes for the EU MDR? If so, this is the job for you.

Responsibilities:

• Responsible for the development of corporate SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR and IVDR.
• Ensures all corporate procedures impacted by the new procedures are identified, assessed for updates, changes needed and that these changes are completed as appropriate.
• Develops training material and provides training to divisional SMEs (Subject Matter Experts) to support the effective implementation of the new process.
• Develops and maintain a quality plan to define all key milestones needed to develop the procedures, system changes, validation etc. to maintain the integrity of the Corporate Quality Systems during the implementation of these new processes.
• Develops and maintains a detailed project plan if needed to support these activities.
• Provides periodic updates on progress, accomplishments, risks and mitigation plans related to the new processes.
• Maintains periodic and effective communication with the divisional and corporate teams involved in the development of the new processes.
• Works with the Information Services (IS) team to identify systems changes needed to support the new requirements.
• Ensures all requirements are clearly communicated to the divisions proactively.
• Ensure all activities are completed on time according to established dates.

Qualifications:
Bachelor's degree (BA) Scientific, Regulatory or Graphics Design - Required U.S. Bachelor's Degree (4-year university degree) or ex-U.S. equivalent. Degree or background in life sciences, technical (engineering) or related field.

• Project Management experience. PMP Certification is a bonus.
• Have 8+ years prior RA experience.
• Minimum five years direct experience in an FDA or EU Regulated environment a must, preferably with respect to the release of labeling and UDI.
• Experience with translation activities desirable
• Experience with EU MDR/IVDR a bonus
• Regulatory Affairs Certification(s) (U.S., EU or Global) desirable.
• The incumbent's regulatory background should include the medical device and IVD.
• A combination of education and experience may be considered.
• Demonstrated strong oral and written communication skills; ability to communicate effectively at multiple levels.
• Current knowledge of relevant US and International Regulations (including but not limited to); FDA QSR (21CFR 820,), ISO Requirements, GMP, IVDD (Directive 98/79/EC), MDD (Directive 93/42/EEC) MDR (Regulation (EU) 2017/745), IVDR (Regulation (EU) 2017/746) requirements) and ability stay abreast of regulations pertinent to medical devices, IVDs, and combination products.
• Practical knowledge of Project Management including experience managing complex projects with cross-functional teams.
• Knowledge of labeling workflow from creation to obsolescence.
• Strong attention to details, and ability to multitask and prioritize tasks.
• Ability to read, interpret and stay abreast of global regulations pertinent to medical devices, IVD products.
• Drives change, challenges the status quo and makes recommendations for improvements to processes.
• Creates tools that help simplify job tasks and shares these with others.
• Prior experience in team management within a matrix organization desirable.
• Foster successful teamwork and morale during stressful situations.

Skills: SOP, FDA, Regulatory Affairs Operations, GMP (Good Manufacturing Practice)

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