Director Global Design Controls & Risk Management

Hologic is committed to enabling healthier lives everywhere every dayand robust Design Controls and Risk Management are fundamental to that mission. As Director Global Design Controls & Risk Management you will be the Global Process Owner providing end-to-end leadership ownership and governance of the enterprise Design Controls and Risk Management framework across all divisions regions and product lines.

In this highly strategic role you will assess and harmonize existing processes define and deploy a unified global framework that meets regulatory requirements and business needs and drive its adoption across the organization. Youll ensure Design Controls and Risk Management are seamlessly embedded into product development and lifecycle management enabling consistent compliance risk reduction and high-quality product outcomes worldwide. As the central authority and primary point of contact for Design Controls and Risk Management processes tools and training youll provide ongoing global support and lead continuous improvement well beyond initial implementation.

Knowledge

• In-depth knowledge of Design Controls requirements and frameworks including FDA 21 CFR 820.30 ISO 13485 and applicable elements of EU MDR/IVDR and other regional regulatory expectations.
• Strong understanding of risk management principles and standards including ISO 14971 and the integration of risk management activities throughout the product lifecycle (concept design development transfer commercialization and post-market).
• Comprehensive understanding of product development lifecycle models (e.g. waterfall V-model hybrid agile) and how Design Controls and Risk Management are applied within different development approaches.
• Knowledge of requirements management design verification and validation methodologies usability/human factors engineering and design transfer practices.
• Familiarity with various risk management tools and methodologies (e.g. FMEA FTA hazard analysis risk matrices usability risk assessment benefit-risk analysis) and their practical application in medical device or similarly regulated environments.
• Knowledge of electronic tools and systems commonly used in Design Controls and Risk Management (e.g. eQMS PLM ALM requirements and risk management software) and their role in enabling traceability and data integrity.
• Familiarity with global quality governance and operating models including central vs. local responsibilities process ownership and harmonization across multiple sites and business units.

Skills

• Proven ability to design harmonize and implement global processes for Design Controls and/or Risk Management across multiple divisions sites and regions.
• Strong capability to interpret and apply regulatory and standard requirements and translate them into clear practical and scalable procedures templates and tools.
• Demonstrated experience in leading cross-functional cross-site process transformation and harmonization initiatives including:
• Process mapping
• Gap assessment
• Roadmapping and change management.
• Ability to lead global deployment efforts including stakeholder engagement communications training and adoption monitoringwith a track record of driving sustainable behavioral and process change.
• Strong facilitation and influencing skills able to manage diverse stakeholder perspectives negotiate trade-offs and secure alignment on standard processes without direct line authority.
• Experience in developing and delivering targeted training and coaching on Design Controls and Risk Management concepts requirements and tools to technical and non-technical audiences globally.
• Skilled at defining and monitoring KPIs and process performance metrics and presenting trends and insights to senior leadership for decision-making.
• Comfortable partnering with Regulatory and Quality to prepare for and support audits/inspections and to respond effectively to Design Controls and Risk Management-related findings.

Behaviors

• Enterprise-minded leader who thinks end-to-end balancing regulatory rigor product innovation and operational practicality.
• Highly collaborative and influential building strong partnerships across R&D Quality Regulatory Clinical Operations and regional business teams.
• Change leader who can articulate a compelling vision for harmonized Design Controls and Risk Management and drive adoption across cultures and regions.
• Data-driven and strategic using performance metrics lessons learned and audit feedback to continuously improve processes and tools.
• Clear confident communicator able to engage senior leadership and diverse teams with clarity and credibility.
• Experience
• Bachelors degree in Engineering Science Quality or a related technical field required. Advanced degree (e.g. MS MEng MBA or related) preferred.
• Minimum 810+ years of experience in medical devices and/or diagnostics with significant focus on Design Controls Risk Management New product Development and establishing DHF strategy
• Demonstrated experience owning or leading Design Controls and/or Risk Management processes at an enterprise multi-site or divisional level.
• Proven track record of leading global or multi-site process harmonization standardization or transformation initiatives.
• Experience interfacing with regulatory bodies and notified bodies on Design Controls and Risk Management topics including participation in audits and inspections.
• Prior experience working in a global matrixed organization and collaborating effectively across R&D Quality Regulatory Clinical Operations and regional business teams strongly preferred.

Experience

• Minimum 810 years of experience in medical devices and/or diagnostics with significant focus on Design Controls Risk Management New product Development and establishing DHF strategy.
• Demonstrated experience owning or leading Design Controls and/or Risk Management processes at an enterprise multi-site or divisional level.
• Proven track record of leading global or multi-site process harmonization standardization or transformation initiatives.
• Experience interfacing with regulatory bodies and notified bodies on Design Controls and Risk Management topics including participation in audits and inspections.
• Prior experience working in a global matrixed organization and collaborating effectively across R&D Quality Regulatory Clinical Operations and regional business teams strongly preferred.
  

Why join Hologic

We are committed to making Hologic the destination for top talent. For you to succeed we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $158000-$280900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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