Senior Regulatory Affairs Manager
2 weeks ago
Job Title
Senior Regulatory Affairs ManagerJob Description
Job Description:
In this role, you will lead a Regulatory Affairs Team for our Magnetic Resonance Imaging (MRI) Business Unit, Bangalore & Pune. You will also be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI portfolio. This portfolio spans imaging medical systems and software and drives Philips' mission to improve the lives of 2.5 billion people by 2030. This position requires building and strengthening regulatory capabilities to drive, but not be limited to, software and AI applications and bring efficiencies through excellence in regulatory operations.
This position reports to the Director-Regulatory Affairs, MRI Business Unit.
Your role:
Lead Regulatory Affairs team, from end to end (product inception through to lifecycle management), driving innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe.
Led the development and deployment of innovative Regulatory strategies with efficiency and compliance, bringing products to market and maintaining them compliantly to support business growth.
This position will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.
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.
Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development.
Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across the spectrum of product lines.
Responsible for monitoring global regulatory landscapes and guiding cross-functional teams in implementing regulation changes.
Communicate new and upcoming changes and facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
Identify areas for improvement in efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate in process improvement teams to affect local or cross-business unit changes.
Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance.
Responsible for the hiring and developing critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.
Led and enabled 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.
Building proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums, etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda
Providing critical input on regulatory risk assessments to support portfolio selection.
You're the right fit if you have the following:
A preferred candidate with a master's degree in engineering or a related field and a minimum of 10-12 years of experience in Regulatory Affairs in the medical device industry, with regulatory submission like 510(k), EU MDR Technical documentation and global registration experience, is a must. (Experience with SaMD, AI, and digital health is a significant advantage.)
Extensive experience and knowledge required of global medical device regulations, requirements, and standards
10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team
Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals
Experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers and international documents or registration of medical devices worldwide.
Strong written, oral, and interpersonal skills required to lead a team as well as individual contributor.
Solution- and detail-oriented, well-organized, self-motivated, and has the ability to negotiate with regulators.
It may require up to 10% travel internationally per business needs.
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 won't 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.
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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 commitment to diversity and inclusion .
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