RA Lead - Netherlands - ASAP Start

A leading Medical Device client of mine is currently seeking a Regulatory Affairs Lead to join them on a contract basis for an ASAP start at their site in the Netherlands.

MAIN RESPONSIBILITIES:

- The creation, and maintenance of high quality regulatory documentation, as needed for all classes of products. Responsibilities are to ensure pre-market clearances are achieved in a timely manner.
- Manage the timely and precise adverse incident reporting processes, recall activities and other post marketing compliance activities.
- Responsible for follow up of Regulatory non-conformances.
- Lead key defined regulatory projects in order to support proportional risk based compliance projects together with an element of horizon scanning to build for the future.
- Build relationships and negotiate with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development, and as appropriate support Business-2-Business teams.
- Accountable to ensure that devices remain in compliance with defined procedure and company policy.
- Consistently drive to create and implement new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
- Drive regulatory processes, such as Regulatory Intelligence, MRL, Global Product Registration Requirements and Market Authorisations etc.

KEY REQUIREMENTS:

- Relevant life sciences degree
- 3 years Regulatory/Quality experience in medical devices.
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA.
- Experience with managing a vigilance/incident system. Experience managing corrections and removals.
- Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC. FDA CFR 820 and RoW an advantage.
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971.
- Demonstrate excellent communication skills.
- Demonstrated organisational, time management and proven leadership qualities.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial.
- Strong critical and analytical skills with excellent judgment and decision making capabilities.
- Excellent team player and motivator.
- Fluent in Dutch and English

VACANCY SUMMARY:

Location: Netherlands

Job type: Contract

Duration: 6 months

Salary/Rate: Negotiable

If you are interested in this role or know anyone who might be please send me an up to date CV and I will be in touch.