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Regulatory Compliance Manager

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Regulatory & Quality Assurance
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JOB SUMMARY

Ensure compliance with regulations and company procedures affecting Hologic products in all countries in EMEA and Canada. Perform periodic audits of internal sites, service centers, third party distribution centers and dealers/distributors to identify potential regulatory compliance risks and implement corrective actions. Manage external and internal audits of the QMS in international locations including interfacing with sites and regional competent authorities during all the steps of identifying, reporting and finalizing any audit non-conformance.

ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

• Interpret and apply regulations to existing Hologic products to ensure compliance with these regulations in all EMEA and Canada sites, dealers and distributors.

• Define, execute, monitor, collate, and publish audit schedules in coordination with divisional and corporate quality compliance teams.

• Participate in global quality compliance teams and support implementation of harmonized procedures.

• Ensure adherence to the company quality audit schedule in international sites.

• Provide monthly reporting to regional and international management on the status of internal and external audits, open actions, overdue activities and future audits.

• Interface with Hologic employees, dealers and distributors regarding quality compliance activities.

• Interact with regulatory agencies in regards to audits and responses until closure.

• Provide training to international employees on audit management.

• Advise and guide management and other personnel in other departments on the interpretation and application of regulations impacting compliance activities.

• Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives.  Assess impact and disseminate throughout the organization for continued regulatory and quality compliance.

• Develop staff skills, abilities, and experiences for succession.

• Perform other related duties as assigned.

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE

• Bachelor or equivalent in biological sciences, life sciences, engineering or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 7 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries; with at least 4 of those years in a wide breath of compliance roles.

• Must have certification as an ISO Lead Auditor.

• Must have experience interfacing with competent authorities regarding audit activities and resolution of observations.

• Must have advanced knowledge of applicable regulations and standards related to medical devices in EMEA and Canada (ISO 13485, Medical Device Regulation, MDSAP, etc.)

• Comfortable leading in a high pressure environment typical of regulatory audits.

• Ability to independently plan, execute, and/or problem solve moderate to complex situations.

• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Must demonstrate initiative, balanced assertiveness working as a team player.

• Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel

• Ability to manage multiple projects.

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit.

• Regularly required to use a computer keyboard, mouse, and monitor. 

• Regularly required to talk and hear. 

• Occasionally required to walk to meeting locations. 

• Required to use close vision and adjust focus. 

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed primarily in an office environment.

• Travel expected not to exceed 5%.

ACCOUNTABILITY

Actions taken by employees in this position have financial impact on end results of the department and the company. 

Hologic offers a dynamic and innovative work environment along with excellent benefits that include bonus potential, stakeholder pension scheme, wellness programme, life assurance and childcare vouchers.

Agency And Third Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current, executed Hologic Agency Agreement signed by a member of the Talent Acquisition Department. In 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 via the Hologic Taleo portal, under these terms or they will not be considered and be will wholly owned by Hologic.”

 

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