The Job's Mission
The Sr. Director of Regulatory Affairs and Quality Assurance EMEA develops and implements the regulatory affairs and quality assurance strategy, in alignment with the business objectives and the evolving regulatory environment. Strategic planning and interfacing throughout the product lifecycle – both within and outside Stryker are among the most important responsibilities for the role. The Sr. Director RAQA is expected to possess ability to navigate ambiguity, demonstrate agility and communicate a strong understanding of the requirements, opportunities, risks and alternatives for developing and maintaining products on the EMEA market.
Key Activities & Accountabilities
Regulatory Framework & Strategy:
- Apply the knowledge of regulatory frameworks and external environments, across EMEA to regulatory solutions throughout the product lifecycle, for all categories of medical devices
- Develops the national, regional and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence (opportunities/risks).
- Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes.
- Accesses and interprets environmental scans and other socioeconomic, scientific and regulatory intelligence to better understand and contribute product positioning, competition, opportunities and to drive regulatory strategy.
- Integrates regulatory considerations into the organization’s global product entry and exit strategy.
- Identifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical products, such as local requirements or standards (ie. Reprocessing requirements for reusable products)
- Manages interactions with regulatory authorities on complex issues throughout the product lifecycle
- Influences changing regulations and guidance, through active engagement in industry associations across EMEA
Product Development & Registration:
- Knowledge of the research and development, preclinical and clinical steps, and related regulations in healthcare product development and their impact for product development across EMEA (ie. Design product fit to EMEA market)
- Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products
- Knowledge of requirements and processes to maintain a product on the market; reporting and surveillance.
- Integrates changes in postmarket strategy based upon consideration of factors such as HTA, reimbursement, group purchasing pressures, state/provincial/regional restrictions and other legislative/regulatory requirements to organization’s business strategies.
- Leads and represents the EMEA regulatory team in execution of product associated events, recalls and product withdrawals.
- Manages interaction and acts as Stryker’s EMEA RAQA representative in audits, inspections and meetings with Competent Authorities
- Develops QMS strategy for the EMEA region, including maintenance of current QMS or evolving QMS to align with new, complex regulatory requirements or business model.
- Management of indirect channels from an RAQA standpoint through education and audits
- Supplier management and onboarding for all supplier of services in scope of RAQA controls
Scientific & Health Concepts:
- Serves as a thought leader in the understanding and application of evolving basic and translational science, regulatory science and public health to develop new approaches to improve the development, review and oversight of healthcare products.
- Identifies and proactively responds to scientific and/or clinical advances that impact healthcare product development and regulation.
- Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally.
- Champions ethical behavior by ensuring integrity in personal and organizational practices, respect for people and principles, including professional, ethical and human values.
- Demonstrates and proactively advocates working together in a spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.
- Ability to clearly convey or exchange information with stakeholders within and outside the organization.
- Communicates the organization’s regulatory positon to business partners.
- Communicates updates to staff to gain alignment.
- Develops and implements effective communication and engagement strategies with partners. Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
- Leverages systems and processes to successfully operate a regulatory function.
- Assesses the data/metrics/performance etc. generated for continuous improvement opportunities within the organization and leverages such information to achieve regulatory objectives.
- Creates a culture of good information practices, protection/safeguarding of information.
- Provides strategic guidance for resource and development planning.
- Understands and utilizes financial information to contribute to organizational business decisions and to make regulatory decisions.
- Develops strategies for resolving complex issues with potential for significant regulatory impact.
- Provides recommendations to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight.
- Oversees regulatory aspects of business relationships to ensure compliance and protect corporate interests.
- Creates or modifies operational infrastructures (e.g., processes, systems, structures, roles, metrics) to support strategic objectives and for driving sustainable results.
- Negotiates regulatory and scientific issues with management.
- Ability to direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession.
- Wins support and buy-in from sponsors, partners and stakeholders by effectively satisfying stakeholder interests and concerns while advocating a clear direction forward; and coaches others to do the same.
- Models, encourages and creates the conditions for an inclusive and respectful work environment. Acts as a catalyst and change agent for creating an inclusive and respectful work environment.
- Models humility by readily taking responsibility for errors, acknowledging opportunities for improvement, pursuing new ideas and perspectives and applying learning.
- Actively engages in talent management practices (selection, promotion, development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.
- Builds and sustains partnership across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
- Leads thorough analysis of situations with appropriate attention to details and the big picture including consideration of impact at multiple levels of the system.
- Makes timely and effective decisions, balancing the need for more information or analysis with the need to be decisive.
- Makes tough or unpopular decisions where mission outcomes supersede the interests/concerns of individuals, constituencies or current situation.
- Factors cultural considerations and impact into decision making.
- Actively leads and engages in policy development, implementation and communication by framing emerging issues and contributing expertise in support of the organization’s vision, strategy, priorities and obligations.
- Ensures knowledge and lessons learned are shared across organizational boundaries.
- Fluency in English essential
- Other European languages are desirable.
- Degree graduate (either/or, law, natural science/ medicine, pharmacy, engineering/business fields) or significant experience working in QA/RA for a Medical Device
The ideal candidate should have proven track record in European quality leadership in a multinational medical device organization including:
- Consistent career progression within the RAQA sector.
- 10/12 years of experience in the regulatory function; with 6+ years professional experience in a pan-European RAQA role is essential. Proven experience of leading high performing; highly enaged teams within a decentralized, matrix organization is an advantage.
- Proven expertise in ISO 13485 Quality Management Systems
- Proven successful track record of implementing and maintaining an ISO certified QA Management System in a Medical Device Industry environment
- Expert level knowledge of Medical Devices Directive
- Ability to communicate efficiently and effectively with all key stakeholders (internal and external); possessing excellent collaboration and strong cross-functional influencing skills.
- Demonstrated ability in liaising with EU Competent Authorities.
- Proven and measurable track record in delivering key projects/systems within QARA environment (eg. CAPA, MDV, Audit management)
- Demonstrated success in building, managing, motivating and developing strong quality teams.
- Demonstrated ability to build engagement and leverage performance management systems to reach business objectives; includes goal setting, performance planning and monitoring, coaching, feedback and performance review
- Experience in an international RAQA role an advantage
- Experience in mergers and acquisitions an advantage.
- Strong interpersonal skills – the individual requires excellent communication skills (written & verbal) plus the ability to relate well to colleagues & stakeholders from varied divisions, markets & cultures.
- Strategic – A strong strategy based thinker who looks at the short and long term impact of decisions.
- High achiever – Is creative & seeks at all times to deliver the best in an agreed timeframe.
- Activator – A self starter who enjoys juggling multiple issues at one time, and has the ability to organize and directdiverse activities in a changing environment, often under time pressure.
- Positive thinker – Through their communication & actions is able to convince and enthuse others.
- Focussed / Disciplined – Can be relied upon to get the job done.
- Is a team player – NOT a ‘committee’ member, but someone who is willing /able to share ideas, plans, responsibilities etc. with others.
- Hold yourself and others to highest standards of ethics and integrity. Always maintains high standards, including company values and policies.
- Change agent - ability to challenge the status quo and the ability to manage and deliver change.
- Result oriented – strong result orientation with a track record for delivering exceptional results.
- Strong leadership and business capabilities.
Work From Home: Not availableTravel Percentage: Up to 75%