Billerica, MA Corporate HeadquartersPosition Summary: This position reports to the Corporate Director of Regulatory Affairs.

 The responsibilities of the position include implementing regulatory plans, interpreting and communicating regulatory policies and procedures to the various manufacturing operations, and successfully interfacing with other corporate functions in order to ensure representation and adherence to regulatory policy and objectives.

 Responsibilities also include ensuring that healthcare products are manufactured, tested, and marketed in compliance with applicable laws and regulations on a worldwide basis.

 Serve as Corporate subject matter expert regarding regulatory affairs issues, and provide consultative guidance on various issues and initiatives.

 Responsibilities: Position responsible for the preparation, monitoring, and maintenance of international regulatory agency pre-market submissions affecting medical device, biologics and InVitro diagnostic products.

Manage the activities associated with regulated product complaints and post market surveillance/vigilance systems.

 Monitor and report on product quality defect trends and corrective actions to assure compliance to international quality system regulations and standards.

 Ensure accurate and timely resolution and closure of all issues.

Monitor relevant international legislative development and maintain knowledge of current regulations and industry standards.

 Participate in formulating and communicating the Corporations position on future legislation that may have a potential impact on the business.

Communicate regulatory requirements affecting business unit operations to stakeholders and manage implementation activities in order to assure business unit compliance.

Maintain the Corporate regulatory agency submission and compliance files.

 Create and, update product technical files and internal standard operating procedures.

Provide guidance and support to manufacturing sites and service laboratories hosting government regulatory agency inspections.

 Review and approve, where required, all post-inspection communication with regulatory agencies.

Responsible for the overall coordination and communication relating to product recalls, safety alerts and advisory notices.

Provide internal training on international regulations affecting the Corporation to various stakeholder groups.

Provide regulatory guidance and support, where applicable, to product design teams as part of the Product Development Procedure (PDP).

Schedule and file, on a timely basis, product licenses, permits and plant registrations with government regulatory agencies.

Provide guidance and support to the global organization relating to regulatory activities, policies and procedures.

Education & Experience Requirements: 7-10+ years progressive, seasoned experience in Regulatory management and organizational leadership within the pharmaceutical, biotechnology or medical device industry; Minimum bachelors degree in related technical area.

Strong knowledge of domestic and international regulatory requirements, including current industry interpretation.

Tactful interfacing and managing communications with outside government agencies to ensure corporate compliance.

Hands on experience in quality system standards and global regulatory management.

Experienced at working in multi-cultural teams.

Easily relates with a broad, culturally diverse team of people.

Must be goal-oriented and results-focused.

Strong written and verbal communication skills required.

Competencies Required: Technical, scientific backgroundInternational RA experience in submissions and complianceCommunication skills (internal/external)Relationship builder, cross-functional partnershipResiliency, flexibilityBroad global perspective cross cultural awareness and sensitivityBenefits: Excellent Salary & Benefits

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