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Senior Regulatory Affairs Specialist EMEA Job

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Date: Apr 14, 2021

Location: Düsseldorf, NW, DE

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Purpose Statement:

Within the Europe Middle East & Africa (EMEA) Regulatory Affairs organization, the main objectives of the role will be to contribute to successful business goals by supporting regulatory activities linked to pre and post-market clinical studies, as well as all associated reporting in the EMEA region.  Participaten direct interaction with regulatory authorities and all Boston Scientific divisional business units, for the entire Boston Scientific product portfolio.

 

Location: This role can be based in one of our main HUB offices (ideally UK - Hemel Hemsted; Spain - Madrid; Italy - Milan; Germany - Düsseldorf / Ratingen; France - Voisins)

 

Key Responsibilites:

  • Establish, manage and maintain good relationships with the local regulatory authorities in the region
  • Interacts directly with regulatory authorities personnel for clinical study related activities, for all buisness units.
  • In direct interaction with the business divisions, clinical, medical and safety teams to support the strategy and conduction of clinical studies in the EMEA region.
  • Coordinate the preparation, review and submit timely clinical study files from the first submission to the closure of the studies.
  • Design and maintain tracking tools for the clinical activities.
  • Provides input and data on regulatory-related issues associated with compliance and achievement of the business plan in the region.
  • Support regulatory advocacy activities in the region and local medical devices industry working groups when related to clinical studies
  • Establish and maintain a good working relationship with regional regulatory afffairs, cross-functional peers and business units to gain positive & timely support.
  • Serve as regulatory consultant to clinical and safety teams as required.
  • Complete the mandatory Quality training subject to the defined timeline.  And ensure compliance with internal Quality system and policy.

 

Quality System Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

Job Scope and Leveling Guidelines:

 

Knowledge

A seasoned, experienced regulatory professional with medical device and associated regulatory expertise (5 years minimum).

Understanding of EU medical device regulations and clinical studies in medical devices, pharmaceutical clinical study experience an advantage

A knowledge of the Medical Device Regulation and clinical trial regulation would be advantageous.

Experience of direct interaction with regulatory bodies.

Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.  General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.

Excellent communication skills as well as excellent written and spoken English are a must.

 

Problem Solving

Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

 

Planning and Organization

Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

 

Discretion / Latitude; Supervision Received; Decision Making

Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

 

Business Relationships and Project Managemet

Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

 

Impact

Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

 

Liasion

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

 

Mentoring

Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

 

 

About us:

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 472693

 


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