EMEA Regulatory Counsel

EMEA Regulatory Counsel

Stryker

Amsterdam or Remote, Netherlands

The Regulatory Counsel EMEA is responsible for providing strategic legal advice to RAQA, Legal and Compliance, GQO, and other stakeholders on regulatory submissions, marketing strategies, engagement with Notified Bodies, Economic Operators, Authorized Representatives, Competent Authorities and other regulatory authorities, NCs and clinical trial compliance. This executive will also assist Stryker stakeholders in aligning Stryker’s presence at and influence on European industry trade associations to advance Stryker strategy.

Essential Responsibilities and Duties:

  • Provide strategic advice to the EMEA RAQA team on regulatory matters and compliance with laws, regulations, and industry standards, including in the areas of clearance and approval, advertising and promotion, product lifecycle management, product classification and post-marketing surveillance in EMEA.
  • Advise with respect to regulations complementary to medical devices business, for example as pertaining to protective equipment, WEEE and REACH.
  • Advise on engagement and interaction with healthcare authorities in EMEA.
  • Partner with Regulatory and Legal colleagues in EMEA and in the US, in particular to advance EMEA strategy important to Stryker and represent EMEA needs at Divisional level.
  • Represent Stryker Europe on industry trade associations and for regulatory law initiatives in alignment with other stakeholders representing Stryker interests.
  • Advise on regulatory matters in connection with Business Development, M&A and integrations impacting Europe.
  • Advise RAQA, global supply, and other stakeholders in the areas of good manufacturing practices, inspections and recalls, ISO 13485, ISO 14971 and quality system regulation.
  • Provide advice on good clinical practices and other matters related to the clinical investigation of new medical devices and technologies.
  • Support the development, improvement, and implementation of relevant internal processes and in-house training.
  • Assist on other matters as needed.

Education and Qualifications:

  • Minimum 8 years applicable professional experience.
  • Demonstrates excellent judgment, professional demeanor, business acumen and leadership.
  • Collaborates with and leads project efforts with legal and business colleagues in a global organization.
  • Initiates, embraces and drives change in a dynamic environment.
  • Influences and empowers others.
  • Recognizes and analyzes dynamic trends and reacts positively to changing needs and demands.
  • Works well independently, in a team and in a highly matrixed environment.
  • Possesses excellent analytical and drafting skills.
  • Has experience providing timely advice in a highly-regulated environment.
  • Demonstrates a commitment to integrity and accountability.
  • Provides guidance and direction to others and demonstrates a strong ability to influence.
  • Possesses excellent communication skills and ability to convey complex principles clearly and concisely.
  • Has a general understanding of business financials and reporting.
  • Possesses excellent organizational skills and is able to manage numerous projects and conflicting demands in a fast-paced environment.
  • Possesses excellent interpersonal skills and the ability to communicate at all levels.
  • Maintains highly sensitive and confidential information.
  • Demonstrates proficiency in the Microsoft Office suite.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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