Post Market Surveillance Manager
il y a 4 semaines
**Role: Post Market Surveillance Manager**
**Location: Zaventem, Belgium**
**Travel: 5%**
**Languages: Fluent English both written and spoken is essential. French, Spanish, or German are an advantage.**
Here at Hologic, it is our purpose to enable healthier lives everywhere, every day.
We are driven by our passion to become the global champion for women’s health.
We achieve this by fulfilling our promise to bring The Science of Sure to life.
Our Post Market Surveillance team supports our international operations to constantly ensure our products meet our, and our customers’, high standards.
**What to expect**:
- Ensuring that all complaints are handled according to the applicable procedures and regulations.
- Responsible for timely submission of vigilance reports and any communication with regulatory bodies and or notified bodies regarding these reports.
- Generation of PMS-related KPIs and reports for senior management.
- Responsible for regular and timely communication of PMS data and/or trend analyses throughout the EMEAC organization.
- Maintain profound PMS knowledge of current and proposed regulations, laws, guidelines standards, and initiatives and update internal Procedures and QMS as applicable.
- Provide real-time support of the post-market process during internal and external audits.
- Responsible for all PMS-related CAPAs, NCEs, and IACAs originating within EMEA.
**We do require some minimum expectations to be considered for the role. Read below to see the experience & skills required**:
- Biomedical engineer or equivalent in biological sciences, life sciences, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in medical device or pharmaceutical industries; some of which must be in a post-market surveillance role.
- Experience working in an international environment.
- Experience working within multidisciplinary teams.
- Advanced knowledge of applicable regulations and standards related to medical devices internationally. (ISO-13485, (EU)2017/745 and /746, CFR803, CFR820,)
- Ability to independently plan, execute, and/or problem-solve moderate to complex situations.
**Why Join Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required so we provide comprehensive training when you join as well as continued development and training throughout your career.
We offer a competitive salary and annual bonus which our talent partner can discuss further with you.
From a benefits perspective, you will join our wide-ranging benefits policy including a pension plan, medical insurance, meal allowance, holidays, parental leave, and many more
**Job Types**: Full-time, Permanent contract
**Benefits**:
- Company car
- Company events
- Food allowance
- Wellness program
- Work from home
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- 1935 Zaventem: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- Post Market Surveillance: 3 years (required)
- Medical Device: 3 years (required)
Work Location: In person
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