Associate Manager, Regulatory and Quality in Belfast at Stryker Corporation

Date Posted: 2/11/2020

Job Snapshot

Job Description

Job Title

RA/QA Manager

Reports To

Snr. RA/QA Manager    

Position Summary

As the Manager of RA/QA for Stryker Belfast, you lead a site team in collaborating confidently within and outside of your site to effectively ensure compliance to the site QMS and current regulatory standards. You support setting direction and managing the quality and regulatory decision-making process for potential field actions, interfacing with company leadership in mission critical decisions.  You will manage a team who will interface with FDA, Canada, EU, and other global health authorities as well as leadership within Stryker.  You use your Quality and Regulatory skills and expertise to protect our customers and ensure we conform to all regulatory requirements around the world.  You lead a team of cross-functional subject matter experts through emerging quality issues, to containment, assessment, and communication phases of potential regulatory actions.

Key Areas of Responsibility

The QA/RA Manager will be responsible for the following activities:

  • Manage top-priority quality-system related outputs of Global strategic planning into program or project proposals that may be implemented by one or more Global Process Owners and form them into short and long-term deliverables.
  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, EU MDR, and individual country requirements).
  • Ensure Regulatory compliance to all current state of the art international standards
  • Ensure optimum state of QMS and regulatory compliance for current and future business needs.
  • Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
  • Manage development and/or modification of Stryker's QMS.
  • Supporting Management Review and Quality Planning Review and related forums.
  • Ensure development and delivery of training for QMS areas of expertise.
  • Responsible for the development, maintenance, and improvement of policies and procedures.
  • Liaise with notified bodies to manage certification changes.
  • Ensure QMS reflects actual activities, business needs and supports Divisional, GQO, and Corporate requirements.
  • Manage QMS activities to support achievement of project milestones.
  • Management of internal and external quality system audits.
  • Strong knowledge of system integration.
  • Negotiates the best path forward based on available time, resources and the voice of the customer
  • Builds strong relationships with local QMS leaders in order to identify improvement opportunities for the Global QMS as it is implemented at a local level, then takes the initiative to develop and propose an improvement approach
  • Builds strong relationships with local and international regulatory leaders in order to identify improvement opportunities as it is implemented at a local level, then takes the initiative to develop and propose an improvement approach
  • Manage development and/or modification of Stryker's regulatory strategies and SOPs.
  • Manage regulatory activities to support achievement of project milestones.
  • Manage registration and pre-market regulatory activities such as technical file and DMR creation

Qualifications Knowledge Skills

  • Qualifications:
  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
  • Specific Knowledge and Experience:
  • 10+ years+ experience within medical device or other regulated industry. Cross-functional experience preferred
  • 3 years+ demonstrated people management; project management experience desired in at least one discipline (RA, R&D, Operations, PMO, etc.)
  • Demonstrated ability to manage cross-functional projects to successful completion
  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position
  • Demonstrated ability to develop a strategic vision
  • Demonstrated versatility and a willingness to manage and lead a team through change and ambiguity.
  • Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills.
  • Ability to present to, influence and build trusting relationships with executives.
  • Demonstrated ability to generate and explain complex opportunity analysis and value assessments accurately.
  • Demonstrated ability to mentor, train, and develop direct and indirect team members.
  • Expertise in quality system standards and regulations, including FDA 21 CFR 820, ISO 13485 and international standards, such as EU MDR and MDSAP
  • Demonstrated ability and expertise in leading quality assurance and regulatory teams as related to medical device design, production and distribution across multiple sites or entities
  • Excellent interpersonal and communication skills with senior management, including technical writing skills
  • Project management skills for projects spanning across different functional and international environments
  • Comfort and familiarity in presenting to leaders of business units
  • Ability to resolve conflict and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome
  • Builds consensus to achieve common goals
  • Able to generate clear policies and directives, as well as detailed procedures and instructions, that add value to the business as well as meet quality and regulatory requirements
  • Can perform at a high level without constant supervision
  • Excellent time management and organizational skills

Work From Home: Occasional

Travel Percentage: Up to 25%

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