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Senior Vice President, Global Regulatory Affairs

Req ID:  2780

Working Location: PENNSYLVANIA, CENTER VALLEY 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Senior Vice President, Regulatory Affairs (SVP-RA) provides strategic vision, leadership, and action plans to ensure implementation of the vision for the Regulatory Affairs function at Olympus. He/she also provides leadership to ensure all Olympus Business Units and Regions get the Regulatory support they need to ensure company growth and regulatory compliance in all countries Olympus supports. 

 

The SVP-RA has the following responsibilities: 

* Ensures the Regulatory Affairs function develops and implements global regulatory strategies for all Olympus product lines, while overseeing all aspects of the regulatory submission development, and interfaces with health authorities. 

* Ensures alignment of regulatory strategies to business strategies with a focus on Growth, Innovation, and Operational Effectiveness across all functional areas.  

* Oversees appropriate discussions with regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.) 

* Ensures global registrations are completed on time and maintained to drive business strategy success. 

* Ensures global regulatory affairs department procedures are created and maintained that comply with applicable domestic and international regulatory laws/standards and Olympus policies and procedures. 

* Responsible for development and harmonization of key regulatory processes that meet the business needs. 

* Mentors, manages and develops direct reports. Trains key personnel on regulatory policies, processes, and SOPs. Determines submission and approval requirements in impacted geographies for new product registrations and post-market changes. 

* Directs the process for preparing and maintaining annual licenses and registrations/listings globally. 

* Provides strategic guidance on regulatory requirements to product development and operations teams. Ensures compliance with the current regulatory procedures and updates the procedures when new regulatory requirements become effective (e.g., EU MDR). 

* Responsible for understanding and influencing legislative/regulatory policy and for advising the wider business (including business units) of upcoming regulations, standards, and requirements and incorporates regulatory trends during regulatory strategy development. 

* Ensures support of product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.

* Provides regulatory support for quality assurance and regulatory compliance activities as well as special projects (e.g. due diligence, EU-MDR etc). 

* Ensures all regulatory files are maintained, well-organized and are always ready to be audited by  competent authorities.

Job Duties

* Creates and maintains a strategic vision to ensure the Regulatory Affairs function at Olympus can compete and win against all Olympus competitors in the regulatory space. 

 

* Creates action plans to ensure the regulatory vision is accomplished. 

 

* Provides strategic leadership for regulatory strategy, agency interactions, and submissions in the Americas, EMEA, Asia and globally.

 

* Provides leadership and oversight for all regulatory submissions, regulatory compliance, regulatory advice and counselling in all areas of development, and commercial regulatory activities across the lifecycle of products in the Americas, EMEA, Asia and globally.

 

* Fosters a strong relationship, partnership, and advocacy with global regulatory authorities relevant to the Olympus product portfolio.

 

* Ensures primary strategic contact with the major global regulatory authorities are in place to enable execution of company regulatory goals.

 

* Oversees core global processes (and process owners) across Regulatory Intelligence, Regulatory Strategy, Regulatory Operations and Global Registration Management. 

 

* Builds and manages a team of global Regulatory staff and support functions including full time staff and independent consultants, as needed.

 

* Continues to build and provide support for the Business Units / Divisions within the global organizational structure 

 

* Develops and manages Global Regulatory Affairs Fiscal Year Budgets.

 

* Provides strategic and tactical direction to drive cross-functional consistency in regulatory approach and execution.

 

* Supports product launch and commercialization activities.

 

* Provides counsel, training, and interpretation of regulatory guidelines or issues to Olympus personnel. 

 

* Keeps peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future regulatory policies, regulations, and standards.

 

* Ensures proper support for medical affairs, advertising and promotion activities and corporate communication activities, including review of publications and investor relations/legal public disclosures as required.

Job Requirements

REQUIRED QUALIFICATIONS


* Bachelor’s degree in Engineering, Medical or Science (or similar) is required. Master’s degree preferred.

 

* Minimum 15 years of experience in Regulatory Affairs within the medical device industry with 7 years of specific leadership and/or management experience.

 

* Experience leading, designing, writing, submission of regulatory filings and correspondence and/or approvals is required, preferably in a space aligned to Olympus’ product portfolio.

 

* Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 40% travel should be expected.

 

PREFERRED QUALIFICATIONS


Previous experience working for a major global regulatory body (e.g. PMDA, FDA, EU Notified Body, NMPA etc) as a Lead Reviewer and RAC Certification preferred.

 

* Experience leading the submission process for major global regulatory approvals. 

 

* Experience supporting commercialization and post-marketing activities and requirements for approved products in major markets, such as North America, EMEA, Japan, China is preferred

 

* Strong collaboration, leadership competencies and strategic business perspectives are required to ensure that sound research, development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities.

 

* Proven track record of successful regulatory approvals and maintenance of regulatory approvals in the medical device space.

 

*  Leadership and interpersonal skills to develop and manage good working relationships with internal departments (R&D, Manufacturing, Supply Chain, Quality etc).

 

* Strong written and verbal communication skills. Experience authoring a range of global regulatory submissions (e.g. 510(k), CE Mark etc); Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).

 

* Experience of working globally – particularly with Japan and APAC as well as US, Europe etc.

 

* Manages, coaches and develops a high performing Regulatory team that meets agreed objectives, and which delivers best practice results, added value and continuous improvements. 

 

* Sets / delivers to department objectives/KPIs and reviews and assesses ongoing performance of direct reports as well as ‘dotted line’ reports in other regions (as may be required). 

 

* Reports on achievement of targets and identifies any actions required. 

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || 


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