Eu Regulatory Affairs Manager/prrc

il y a 1 semaine

Brussels, Belgique Innova Medical Group, Inc. Temps plein

The EU Regulatory Affairs Manager maintains the official record for all European product registrations, related to the design, manufacture, and sale of medical device and in-vitro diagnostic products. Also, they will update the technical files with design changes and ensure, that additional submissions are completed. The EU Regulatory Affairs Manager will be the PRRC (Person Responsible for Regulatory Compliance) for Innova Medical Group, Inc. and supports the Regulatory Associates in maintaining regulatory approvals in keeping with our goals. You will reside in one of the EU Member States.

**You Will**:

- Maintain all necessary regulatory registrations, approvals and certifications to facilitate the sale of products in each regulatory market, including Europe and other countries as determined by our goals. Manage all Technical file documentation used for product submission.
- Ensure all product changes are incorporated into product technical files
- Verify, with geography RA specialists, to determine if product/technical file require additional submissions.
- Participate in product development activities ensuring local regulatory standards are understood and implemented to support regulatory submissions.
- Manage assigned staff and contracted consultants.
- Manage departmental activities per approved budget and annual operating plan.
- Monitor and improve regulatory and compliance programs.
- Help with any other responsibilities as assigned.

**PRRC **per IVDR Article 15, clause 3 will ensure:

- The conformity of the devices is checked following the quality management system under which the devices are manufactured, before a device is released;
- The technical documentation and the EU declaration of conformity are drawn up and updated;
- The post-market surveillance obligations are complied with following Article 10(10) [10(9);
- The reporting obligations referred to in Articles 87 to 91 [82 to 86] are fulfilled;

**You Have**:

- Must have knowledge of EU and global registration and submission requirements. Must have experience with EU and global product submissions and market approvals.
- Specific knowledge of IVD products preferred.
- Experience with both IVDD and IVDR in Europe preferred.
- Excellent management skills, both of individuals and projects.
- Ability to resolve conflicts.
- Ability to translate our strategy and goals into a regulatory/compliance program. Based on requirements, ability to provide regulatory approach.
- Must have an ability to accomplish goals according to business needs.
- Bachelor's degree in Engineering, Biological Science or related technical discipline, desirable.
- 7+ years' experience in Regulatory Affairs for an in-vitro diagnostic or medical device company, required.

**PRRC Qualifications (Required Experience and Education), one of two options**
- A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline. Any qualification acquired outside the EU, including any university diplomas or certificates, has been recognized by an EU Member State as equivalent to the EU corresponding qualification.

AND
- At least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. The professional experience in regulatory affairs or in quality management systems are related to the EU requirements in the field - MDCG Guidance 2019-7.
- Four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

**About the Company**:
At Innova Medical Group, we believe better healthcare outcomes around the globe are within reach - and it starts with scalable and cost-effective screening and diagnostic options. As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova helps improve lives with testing, monitoring, and implementing medical care.

We quickly became the world's largest provider of COVID-19 tests, and we are determined to execute on this model across infectious disease, other chronic conditions and wellness, thereby empowering the global population to take control of their own care procurement and health decisions.

Our goal is to play an important role in care pathways by vitally contributing to improving patient outcomes and ultimately cutting overall treatment costs and bettering lives.

Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.
- We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportu

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