Regulatory Director of Medical Devices and Equipment
MilliporeSigma


Job Info


A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Exciting opportunity to join MilliporeSigma in a key global leadership position heading the Life Sciences Regulatory Management Medical Devices and Equipment organization. As the Head of - Devices and Equipment you will develop a global regulatory strategy aligned with key stakeholder (commercial, marketing, R&D, QA) goals and objectives. You will collaborate to draft global regulatory policy, processes, and procedures, provide advice and guidance to stakeholders, your direct reports, and external business partners. Your team will execute your strategy to ensure regulatory submissions, registrations, and compliance topics are adequately addressed. At manufacturing site your team will interact with their local counterparts with your support and leadership, attending to all local regulatory needs, including audit support, labeling, compliance, product portfolio expansions and new product introductions. MilliporeSigma plays an integral part in the life science community, harnessing our passion and innovation to help life science professionals and companies around the world. As science advances, we advance with it, offering new insight and cutting-edge technologies helping our customers solve the world's most challenging human health issues. Our promise to our customers is that we'll be there every step of the way.

Your Role:

  • Lead a global subject matter expert group for medical devices and ivitro diagnostic (IVD) devices.
  • Integrate global regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. Responsible for strategic planning and interfacing throughout the medical device and equipment lifecycle, both within the organization and with a diverse range of external groups.
  • Leading and providing strategic regulatory guidance and delivering the global regulatory strategy for product development, manufacturing and registration on Medical Devices, Assays and Equipment.
  • Building and maintaining a credible relationship with relevant regulatory authorities with effective written and verbal communication related to registration of Medical Devices and Equipment.
  • Carrying out regulatory registrations and listing. Compiling and carrying out regulatory submissions - original, change submission and annual reporting for the Medical Device, Biologics and EEE portfolio. Supporting country groups in registration and listing activities.
  • Manages numerous, potentially cross-discipline teams of professionals and is accountable for the performance and results of the teams.
  • Provide guidance and coordinate registration, notification, and listing activities together with the local regulatory units of the sites, local agents, and subsidiaries. Develop and maintain systems for tracking and reporting product submissions, registrations, licenses, approvals, etc. of all IVDs, Medical Devices worldwide.
  • Ensures that relevant changes to product registrations and listings are properly notified to the relevant authorities.
  • Ensuring manufacturing sites and distribution comply with regulatory requirements and good regulatory practices.
  • Responsible for vigilance reporting to Competent Authorities.
  • Prepare regulatory assessments and regulatory action plans in the product development process (PDP)
  • Interface/partner with Marketing, Commercials, Manufacturing sites, Operations, Distribution, Trade Compliance, R&D, QA, QC and Regional Regulatory units.
  • Leading new global strategic Medical devices and Equipment regulatory projects within MilliporeSigma Life Science
  • Provide regulatory support and guidance to marketing and commercials via seminars / trainings / events.

Who You Are:
  • Graduate degree (e.g. pharmacist, chemist, biologist, engineer) that provides knowledge of theories, principles and concepts within Regulatory Management
  • Minimum 10 years of extensive professional experience including managerial experience in diverse roles
  • Requires in-depth knowledge of market, competitors and authority landscape
  • Extensive knowledge on regulations
  • Excellent communication, negotiation and leadership skills
  • Excellent project management skills

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 219944

Location: Rocklin

Career Level: D - Professional (4-9 years)

Working time model: full-time



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