Senior Regulatory Affairs specialist

Job title:

Senior Regulatory Affairs Specialist

Your role:

• Developing and executing the regulatory strategy for new product development, design changes and field safety corrections for US, EU, Canada and RoW.
• Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development.
• Responsible for product registrations/approvals for their responsible products within IGT-S portfolio.
• Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process.
• Review and validate labelling, marketing materials, claims substantiation evidence, clinical protocols to maintain compliance with global requirements.
• Keep abreast of current regulatory procedures and changes.
• Provide critical input and guidance on regulatory change assessments, risk assessments and regulatory requirements implementation.
• Participate in internal audits and play a key role in (external) audits, related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
• Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
• Identify areas for improvement in terms of efficiency and compliance for internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead and/or participate in process improvement teams to affect local or cross-business unit changes.
• Provide strategic guidance, mentor and coach the RA resources and project team by being a Regulatory subject matter expert.
• Establishes operational objectives and work plans.
• Work according to the business applicable processes and as ambassador of the Philips values.

Youre the right fit if: (4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required) 2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation 3. Education- Bachelors/Master of Science degree 4. Anything else-

Project planning and management skills (preferred)

Excellent verbal, written communication skills (English) & interpersonal skills.

Good communicator and team player who is able to work in a flexible and goal-oriented environment

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business . Discover our rich and exciting history . Learn more about our purpose . If you re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .