Specialist 2, Regulatory Affairs
Posted on Jul 16, 2021 by Aerotek
An exciting opportunity has arisen for a Jr. Regulatory Affairs Specialist in Medical Device, supporting our client's regulatory submissions to new markets.
Covering our European and US markets, you'll be responsible for managing regulatory submissions in support of new product developments, and changes to our existing devices. You'll be liaising directly with regulatory authorities and be the point of contact for any queries.
On a day-to-day basis, you can expect to be reviewing and approving documentation to support the submissions of regulatory documentation, along with advising on current, and future, Medical Device regulations to ensure compliance across the business.
- Bachelor/Master Degree in life sciences or engineering; or Advanced Degree (PhD) with 1-2 years of professional knowledge) is preferred.
- Ensuring that the company's products comply with the regulations set up by government agencies
- Advising engineering and other support functions, as well as manufacturing on regulatory requirements
- Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
- Creating, reviewing and maintaining regulatory related technical documentation
- 1-2 years in European Medical device industry especially with regulatory, quality or engineering
- Knowledge of ISO 13485 and ISO 9001, QSR
- Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
- MEDDEV guidance documents applicable to Medical Devices products and processes
- Knowledge of FDA requirements registration requirements in further global markets would be an asset
- Strong understanding of Risk Management process, label and labelling, change management is desired
- Proven exceptional written and oral communication skills
- Able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to cope with internal guidelines change management
- Some flexibility in working hours is required
- Language proficiencies:
- English spoken and written
- German would be a plus.
- Familiarity with Technical Documentation structure according to STED required
- Team work oriented, within a multi-functional and multi-national team
- Strong interpersonal and diplomatic skills
- Customer/service orientation
- High analytical, planning and organizational skills; able to set priorities
- Strong knowledge and skills in MS Office
Job Title: Specialist 2, Regulatory Affairs
Location: Solothurn, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website
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