QA manager i spennende norsk biotek

Description

Regenics is a small biotech company primarily in the advanced wound care space, currently poised for expansion. The company is backed by competent investors, with a recent capital raise.

We are seeking a dedicated and experienced QA manager to ensure that we meet the standards of quality to prepare for clinical trials and market approval. Our lead innovation, Collex, is a hydrogel wound dressing with an integrated bioactive substance, developed to improve hard-to-heal wounds such as burns and chronic wounds. Collex has demonstrated excellent results in the pre-clinical stage.

As the leader of our Quality Assurance efforts, you'll play a pivotal role in refining our eQMS system using BizzMine, adhering to the applicable ISO standards. You will ensure that every development phase of the ISO 13485 Design control processes are met, meeting the high standards of quality and traceability. In addition, you will evaluate the risks according to ISO 14971 and ISO 22442 and biocompatibility according to ISO 10993.

You will be part of a small dedicated and enthusiastic team, with the understanding of the need for flexibility and desire to chip in, and together deliver what’s required to build the future of the company.

Key responsibilities for the position:

As the Quality Assurance Manager, you will assume comprehensive oversight of our Quality Management System. Your responsibilities will encompass, but not be confined to:

• Review and update existing SOPs and create new ones as needed.
• Amend working instructions, templates, and forms as necessary.
• Ensure strict adherence to pertinent “GxP” guidelines and regulations.
• Conduct internal audits.
• Lead the Design control phases in accordance with ISO 13485.
• Evaluate and finalize risk assessments, including GSPR.
• Oversee the supplier/vendor quality assessment process, including audits where applicable.
• Review existing supplier QA agreements and generate new ones as required.
• Guarantee timely resolution of audits and proper review and endorsement of CAPA plans.
• Provide support for preparation activities related to Regulatory Authority submission and approval.

Documented qualifications and experience:

The holder of this position should have the following documented qualifications and experience:

• MSc. or BSc. within Life Sciences or related field.
• Experience working with Quality Management Systems (QMS) within the Life Science sector.
• Proficient in EU/US regulations pertaining to one or more “GxP” areas.
• Prior experience with ISO 13485 and being part of medical device development would be preferred.
• Proficiency in verbal and written communication in English. Norwegian language proficiency is beneficial, but not a requirement.

A successful candidate will possess an analytical and structured mindset, have strong collaborative abilities and a documented track of delivery. You should be able to understand the relevant standards in a way that also takes into consideration the relevant business aspects. You should enjoy the challenges of growing a start-up company and being hands on.

What we offer:

• Opportunities for continuous learning and professional development through tailored training, external courses and diverse work tasks.
• An inclusive and dedicated team.
• Access to attractive pension schemes and stock option programs, aligning your success with the company's prosperity.
• Access to the ecosystem of the ShareLab incubator within Oslo Science Park, fostering scientific and social engagement as well as participation in quality assurance forums through our membership in The Life Science Cluster (TLSC).

We're eager to welcome you to our team and embark on this transformative journey together.

Note: an application without a motivation letter will not be evaluated. We would like to see “why Regenics” and “what can I bring to the table”. We are reviewing applications on a rolling basis.

Location

The holder of this position will be based in Oslo.