Jobbtitel: Senior Regulatory Affairs Specialist

Arbetsbeskrivning:

Cochlear´s global mission is to help people hear and be heard. Cochlear Bone Anchored Solutions AB is the division of Cochlear that designs and manufactures the world´s leading bone anchored solutions. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people´s lives. Situated in Mölnlycke, outside Gothenburg, Sweden, the head office employs approximately 200 people whose responsibilities include research, product design and development, marketing, quality and regulatory, manufacturing, distribution and administration for all the Baha® and Vistafix® products. Cochlear Bone Anchored Solutions AB offers you a modern environment in which you can work with passionate professionals to apply your specialist expertise and skills to bring the most advanced technologies to the market.

We Offer Challenging Work with Real Meaning

The work we do at Cochlear helps people with hearing loss to connect to others and live full lives.

We are recruiting for a Senior Regulatory Affairs Specialist in our Regulatory Team within Q&R department. In this permanent role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge and ambitions to get the products regulatory approved globally.

The role include:

develop regulatory strategies.

provide regulatory support to project teams, with respect to regulatory expectations and documentation needs.

ensure product and process changes are reviewed and assessed from a regulatory standpoint.

interpret regulatory requirements and guidelines and provide analysis and advice on pre- and post-market compliance.

support submissions worldwide in line with the company piorities and authorities requirements.

You Bring Your Skills and Experience

As we grow bone conducted solutions business, we are looking for people with highly specialised skills and capabilities who share our passion for delivering quality hearing solutions to our customers.

To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience:

Master of Science or equivalent.

Experience from Regulatory Affairs in a medical device company with high risk devices.

Knowledge in MDD and AIMDD conformity assessments.

Knowledge in Design Control requirements.

Skilled in English, writing and speaking.

An understanding for the importance of details but also able to see the big picture.

Desirably experience from FDA submissions (510(k) and PMA).

Desirably experience from a medical device company working with electronics and software.

The ability to solve problems and collaborate to get work done that delivers benefits for Cochlear?s customers.

A responsible attitude to working safely and building the safety culture.

A commitment to lifelong learning and development.

We Reward Performance and Offer Flexible Benefits

We reward and recognise people who perform their work in a way that is aligned to Cochlear´s mission and values and that contributes to Cochlear´s growth. To help us attract and retain people with the right skills we aim to pay competitively in the health science and technology markets. To encourage people to achieve outcomes aligned to Cochlear´s strategy we link the incentives we offer to both the financial performance of the company and individual achievement.

Application Information

Due to vacation period interviews will be held during August.

Arbetsgivare Namn: COCHLEAR BONE ANCHORED SOLUTIONS AB

Arbetsgivare adress: BOX 82 43522 MÖLNLYCKE

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Arbetsgivare telefonnummer: 031-7924400

Jobb kort beskrivning: Pharmacists

Land: Sweden

Område: Västra Götalands län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text