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Regulatory Compliance Manager

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Regulatory & Quality Assurance
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1840 Total Views
Thanks for your interest in the Regulatory Compliance Manager position. Unfortunately this position has been closed but you can search our 245 open jobs by clicking here.

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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